Methods of using ultrasonically powered surgical instruments with rotatable cutting implements

ABSTRACT

In one general aspect, various embodiments are directed to methods for treating tissue within an aqueous environment. Various methods may include introducing a cutting implement of a surgical instrument into the aqueous environment. The cutting implement may have at least one cutting surface thereon and at least one ultrasonic portion thereon and be selectively rotatable within a hollow sheath. The methods may include rotating or rotatably oscillating the cutting implement within the hollow sheath for tissue cutting purposes. The cutting implement may also be retained in a position wherein the ultrasonic portion of the cutting implement may be applied to tissue and then have ultrasonic motion applied thereto.

BACKGROUND

The present disclosure generally relates to ultrasonic surgical systemsand, more particularly, to ultrasonic systems that allow surgeons toperform cutting and coagulation of tissue.

Over the years, a variety of different types of non-ultrasonicallypowered cutters and shaving devices for performing surgical procedureshave been developed. Some of these devices employ a rotary cuttinginstrument and other devices employ a reciprocating cutting member. Forexample, shavers are widely used in arthroscopic surgery. These devicesgenerally consist of a power supply, a handpiece, and a single-use endeffector. The end effector commonly has an inner and outer tube. Theinner tube rotates relative to the outer tube and will cut tissue withits sharpened edges. The inner tube can rotate continuously oroscillate. In addition, such device may employ a suction channel thattravels through the interior of the inner tube. For example, U.S. Pat.No. 4,850,354 to McGurk-Burleson, et al., discloses a non-ultrasonicallypowered surgical cutting instrument that comprises a rotary cutter forcutting material with a shearing action. It employs an inner cuttingmember which is rotatable within an outer tube.

U.S. Pat. No. 3,776,238 to Peyman et al. discloses an ophthalmicinstrument in which tissue is cut by a chopping action set-up by thesharp end of an inner tube moving against the inner surface of the endof an outer tube. U.S. Pat. No. 5,226,910 to Kajiyama et al. disclosesanother surgical cutting instrument that has an inner member which movesrelative to an outer member to cut tissue entering through an aperturein the outer member.

U.S. Pat. No. 4,922,902 to Wuchinich et al. discloses a method andapparatus for endoscopic removal of tissue utilizing an ultrasonicaspirator. The device uses an ultrasonic probe which disintegratescompliant tissue and aspirates it through a narrow orifice. U.S. Pat.No. 4,634,420 to Spinosa et al. discloses an apparatus and method forremoving tissue from an animal and includes an elongated instrumenthaving a needle or probe, which is vibrated at an ultrasonic frequencyin the lateral direction. The ultrasonic movement of the needlebreaks-up the tissue into fragments. Pieces of tissue can be removedfrom the area of treatment by aspiration through a conduit in theneedle. U.S. Pat. No. 3,805,787 to Banko discloses yet anotherultrasonic instrument that has a probe that is shielded to narrow thebeam of ultrasonic energy radiated from the tip of the probe. In oneembodiment the shield extends past the free-end of the probe to preventthe probe from coming into contact with the tissue. U.S. Pat. No.5,213,569 to Davis discloses a phaco-emulsification needle which focusesthe ultrasonic energy. The focusing surfaces can be beveled, curved orfaceted. U.S. Pat. No. 6,984,220 to Wuchinich and U.S. PatentPublication No. US 2005/0177184 to Easley disclose ultrasonic tissuedissection systems that provide combined longitudinal and torsionalmotion through the use of longitudinal-torsional resonators. U.S. PatentPublication no. US 2006/0030797 A1 to Zhou et al. discloses anorthopedic surgical device that has a driving motor for driving anultrasound transducer and horn. An adapter is provided between thedriving motor and transducer for supplying ultrasonic energy signals tothe transducer.

While the use of ultrasonically powered surgical instruments provideseveral advantages over traditional mechanically powered saws, drills,and other instruments, temperature rise in bone and adjacent tissue dueto frictional heating at the bone/tissue interface can still be asignificant problem. Current arthroscopic surgical tools includepunches, reciprocating shavers and radio frequency (RF) devices.Mechanical devices such as punches and shavers create minimal tissuedamage, but can sometimes leave behind ragged cut lines, which areundesirable. RF devices can create smoother cut lines and also ablatelarge volumes of soft tissue; however, they tend to create more tissuedamage than mechanical means. Thus, device which could provide increasedcutting precision while forming smooth cutting surfaces without creatingexcessive tissue damage would be desirable.

Arthroscopic surgery involves performing surgery in the joint space. Toperform the surgery, the joints are commonly filled with pressurizedsaline for distention and visualization. Ultrasonic instruments whichmay be used in such surgeries must withstand the fluid pressure withoutleaking. However, conventional ultrasonic instruments generallyexperience significant forces during use. Current seals on ultrasonicdevices are generally not robust enough to withstand this environmentwithout leaking.

It would be desirable to provide an ultrasonic surgical instrument thatovercomes some of the deficiencies of current instruments. Theultrasonic surgical instruments described herein overcome many of thosedeficiencies.

It would also be desirable to provide more robust sealing arrangementsfor ultrasonic surgical instruments used to cut and coagulate in theaqueous environment of arthroscopic surgery.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of various embodiments of theinvention at the time, and should not be taken as a disavowal of claimscope.

SUMMARY

In connection with one general aspect, there is provided a method oftreating tissue within an aqueous environment. The method may includethe action of introducing a cutting implement of a surgical instrumentinto the aqueous environment wherein the cutting implement has at leastone cutting surface thereon and at least one ultrasonic portion thereon.The cutting implement may be selectively rotatable within a hollowsheath between cutting positions wherein the at least one cuttingsurface may be exposed to tissue and a ultrasonic position wherein theultrasonic portion may be exposed to the tissue. The method may furtherinclude rotating the cutting implement within the outer sheath andcutting tissue with the at least one cutting surface of the rotatingcutting implement. The method may further include positioning thecutting implement in the ultrasonic position and retaining it in thatposition. The method may also include applying pressure to tissue withthe exposed ultrasonic portion of the cutting implement and applyingultrasonic motion to the cutting implement.

In connection with another general aspect, there is provided a method oftreating tissue within an aqueous environment. In various embodiments,the method includes introducing a cutting implement of a surgicalinstrument into the aqueous environment. The cutting implement may haveat least one cutting surface thereon and at least one ultrasonic portionthereon. The cutting implement may be selectively rotatable within ahollow sheath between cutting positions wherein the at least one cuttingsurface may be exposed to tissue and a ultrasonic position wherein theultrasonic portion may be exposed to the tissue. The method may furtherinclude rotatably oscillating the cutting implement within the outersheath to the ultrasonic position and cutting tissue with the at leastone cutting surface of the rotatably oscillating cutting implement. Inaddition, the method may include positioning the cutting implement inthe ultrasonic position and retaining it in that position. The methodmay further include applying pressure to tissue with the exposedultrasonic portion of the cutting implement; and applying ultrasonicmotion to the cutting implement.

FIGURES

The features of various non-limiting embodiments are set forth withparticularity in the appended claims. The various non-limitingembodiments, however, both as to organization and methods of operation,together with further objects and advantages thereof, may best beunderstood by reference to the following description, taken inconjunction with the accompanying drawings as follows.

FIG. 1 is a schematic view of a non-limiting embodiment of a surgicalcontrol system;

FIG. 1A is a perspective view of a non-limiting embodiment of controlsystem enclosure;

FIG. 1B is a perspective view of another non-limiting embodiment of acontrol system enclosure arrangement;

FIG. 2 is a cross-sectional view of anon-limiting embodiment of ahandpiece;

FIG. 3 is a partial cross-sectional view of an ultrasonic surgicalhandpiece that may be employed with various non-limiting embodiments;

FIG. 4 is a cross-sectional view of a portion of a non-limitingnosepiece embodiment;

FIG. 5 is a partial exploded assembly view of a non-limiting nosepieceembodiment;

FIG. 6 is a partial cross-sectional view of a non-limiting embodiment ofa surgical instrument handpiece;

FIG. 7 is a perspective view of the non-limiting surgical instrumenthandpiece embodiment of FIG. 6;

FIG. 8 is a partial cross-sectional view of another non-limitingsurgical instrument handpiece embodiment;

FIG. 9 is a partial cross-sectional view of another non-limitingsurgical instrument handpiece embodiment;

FIG. 10 is a perspective view of the surgical instrument handpieceembodiment depicted in FIG. 9;

FIG. 11 is a partial exploded assembly view of a non-limiting couplingassembly embodiment for coupling a motor to a transducer assembly;

FIG. 12 is a side view of a thin plate member and drive shaftarrangement of a non-limiting coupling assembly embodiment;

FIG. 13 is an end view of the non-limiting thin plate member embodimentof FIG. 12;

FIG. 14 is a side view of a non-limiting thin plate member and driveshaft arrangement of another non-limiting coupling assembly embodiment;

FIG. 15 is an end view of the non-limiting thin plate member embodimentof FIG. 14;

FIG. 16 is a partial cross-sectional view of another non-limitingsurgical instrument handpiece embodiment;

FIG. 17 is a partial perspective view of a non-limiting outer sheath andblade embodiment;

FIG. 18 is a partial perspective view of the non-limiting bladeembodiment depicted in FIG. 17;

FIG. 19 is a partial bottom perspective view of the blade of FIGS. 17and 18;

FIG. 20 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 21 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 22 is a partial perspective view of a distal end of anothernon-limiting outer sheath and blade arrangement;

FIG. 23 is a partial perspective view of a distal end of anothernon-limiting outer sheath and blade arrangement;

FIG. 23A is a side view of a portion of the non-limiting outer sheathembodiment depicted in FIG. 23;

FIG. 24 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 25 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 26 is a partial perspective view the non-limiting blade embodimentof FIG. 25 within a distal end of another non-limiting outer sheathembodiment;

FIG. 27 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 28 is a partial perspective view the non-limiting blade embodimentof FIG. 27 within a distal end of another non-limiting outer sheathembodiment;

FIG. 29 is a partial cross-sectional end view of the non-limiting bladeand outer sheath embodiments of FIG. 28;

FIG. 30 is a side view of a portion of another non-limiting bladeembodiment;

FIG. 31 is a partial perspective view of the non-limiting bladeembodiment of FIG. 30 within a distal end of another non-limiting outersheath embodiment;

FIG. 32A illustrates a first rotational position of the non-limitingblade embodiment of FIGS. 30 and 31 within the outer sheath embodimentof FIG. 31;

FIG. 32B illustrates a second rotational position of the non-limitingblade embodiment of FIGS. 30 and 31 within the outer sheath embodimentof FIG. 31;

FIG. 32C illustrates a third rotational position of the blade embodimentof FIGS. 30 and 31 within the outer sheath embodiment of FIG. 31;

FIG. 32D illustrates a fourth rotational position of the bladeembodiment of FIGS. 30 and 31 within the outer sheath embodiment of FIG.31;

FIG. 33 is a perspective view of a portion of another non-limiting bladeembodiment;

FIG. 34 is a partial perspective view of the blade embodiment of FIG. 33within a non-limiting outer sheath embodiment;

FIG. 34A is a partial perspective view of another non-limiting blade andouter sheath embodiment;

FIG. 35 is a perspective view of a portion of another non-limiting bladeembodiment;

FIG. 36 is a partial cross-sectional view of another non-limitingultrasonic surgical instrument embodiment;

FIG. 36A is a partial cross-sectional view of a nosepiece portion ofanother non-limiting surgical instrument embodiment of the presentinvention;

FIG. 37 is a partial perspective view of a distal end of thenon-limiting outer sheath and blade arrangement of FIG. 36;

FIG. 38 is a cross-sectional view of distal portions of the outer sheathand blade embodiments depicted in FIG. 37 cutting tissue;

FIG. 39 illustrates use of the surgical instrument embodiment of FIG. 36in connection with performing a discectomy;

FIG. 40 depicts further use of the surgical instrument embodiment ofFIG. 36 in connection with performing a discectomy;

FIG. 41 is a side elevational view of the surgical instrument embodimentof FIG. 36 with a selectively retractable safety sheath mounted thereon;

FIG. 42 is a partial perspective view of the retractable safety sheathembodiment illustrated in FIG. 41 starting to be retracted from a closedposition;

FIG. 43 is another partial perspective view of the retractable safetysheath embodiment illustrated in FIGS. 41 and 42 with the safety sheathretracted to an open position;

FIG. 44 is another partial perspective view of the retractable safetysheath embodiment illustrated in FIGS. 41-43 with the safety sheathretracted to an open position;

FIG. 45 is a side elevational view of a portion of the outer sheath andsafety sheath embodiments illustrated in FIGS. 41-44 with the safetysheath shown in cross-section in an open position;

FIG. 46 is a perspective view of a portion of another non-limiting bladeembodiment;

FIG. 47 is a side view of a portion of another hollow outer sheath andblade arrangement of another non-limiting embodiment;

FIG. 48 is a cross-sectional view of another non-limiting bladeembodiment;

FIG. 49 is a cross-sectional view of another non-limiting bladeembodiment;

FIG. 50 is a cross-sectional view of another non-limiting bladeembodiment;

FIG. 51 is a cross-sectional view of another non-limiting bladeembodiment;

FIG. 52 is a partial cross-sectional view of another non-limiting outersheath and blade embodiment;

FIG. 53 is another partial cross-sectional view of the outer sheath andblade embodiment of FIG. 52 interacting with body tissue;

FIG. 54 is an end cross-sectional view of the outer sheath and bladearrangement depicted in FIGS. 52 and 53 interacting with body tissue;

FIG. 55 is a partial perspective view of another non-limiting outersheath embodiment;

FIG. 56 is a partial perspective view of another non-limiting outersheath embodiment;

FIG. 57 is a partial cross-sectional view of the outer sheath embodimentof FIG. 56 supporting another non-limiting blade embodiment;

FIG. 58 is a partial perspective view of another non-limiting outersheath embodiment;

FIG. 59 is a cross-sectional view of another non-limiting outer sheathand blade embodiment;

FIG. 60 illustrates an angle between the cutting edges formed on anon-limiting outer sheath embodiment;

FIG. 61 is a perspective view of another non-limiting outer sheathembodiment;

FIG. 62 is a cross-sectional view of the outer sheath and bladeembodiment of FIG. 61;

FIG. 63 is a perspective view of another non-limiting outer sheathembodiment;

FIG. 64 is a cross-sectional view of the outer sheath and bladeembodiment of FIG. 63;

FIG. 65 is a perspective view of another non-limiting outer sheathembodiment;

FIG. 66 is a cross-sectional view of the outer sheath and bladeembodiment of FIG. 65;

FIG. 67 is a cross-sectional end view of another non-limiting outersheath and blade arrangement;

FIG. 68 is a partial side cross-sectional view of the outer sheath andblade arrangement of FIG. 67;

FIG. 69 is a partial side view of a distal end portion of the outersheath and blade arrangement of FIGS. 67 and 68;

FIG. 70 is a side view of a non-limiting handpiece housing embodimentattached to the outer sheath and blade arrangement of FIGS. 67-69;

FIG. 71 depicts a method of using the surgical instrument embodiment ofFIG. 70;

FIG. 72 depicts another method of using the surgical instrumentembodiment of FIG. 70;

FIG. 73 depicts another method of using the surgical instrumentembodiment of FIG. 70;

FIG. 74 is a partial side cross-sectional view of another non-limitingsurgical instrument embodiment;

FIG. 75 is a perspective view of a portion of the outer sheath and bladearrangement employed with the surgical instrument embodiment depicted inFIG. 74;

FIG. 76 is an end view of the outer sheath and blade arrangement of FIG.75;

FIG. 77 is a cross-sectional end view of the sheath and bladearrangement of FIGS. 75 and 76;

FIG. 78 is a side view of another non-limiting ultrasonic surgicalinstrument embodiment;

FIG. 79 is a partial cross-sectional view of a non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 80 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 81 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 82 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 83 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment, prior to being crimped in position;

FIG. 84 is a partial cross-sectional view of the seal embodiment of FIG.83 after being crimped in position;

FIG. 85 is a partial cross-sectional view of another non-limiting sealembodiment between a two-piece hollow sheath and a waveguide portion ofan ultrasonic implement embodiment;

FIG. 86 is a partial cross-sectional exploded assembly view of anothernon-limiting seal embodiment between another two-piece hollow sheath anda waveguide portion of an ultrasonic implement embodiment;

FIG. 87 is a partial perspective view of a portion of the two piecehollow sheath embodiment of FIG. 86;

FIG. 88 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 89 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 90 is a partial cross-sectional view of another non-limiting sealembodiment between a hollow sheath and a waveguide portion of anultrasonic implement embodiment;

FIG. 91A is an illustration depicting an initial position of two cuttingedge embodiments preparing to cut tough tissue;

FIG. 91B is a second position of the cutting edges and tissue of FIG.91A;

FIG. 91C is a third position of the cutting edges and tissue of FIGS.91A-B;

FIG. 91D is a fourth position of the cutting edges and tissue of FIGS.91A-C;

FIG. 92 is a perspective view of a portion of a non-limiting cuttingblade and bushing embodiment;

FIG. 92A is a partial cross-sectional view of a portion of the blade andbushing embodiment of FIG. 92 installed within an inner sheath of anon-limiting surgical instrument embodiment;

FIG. 93 is a cross-sectional view of a portion of the blade and bushingembodiment of FIG. 92 in a non-limiting surgical instrument embodiment;

FIG. 94 is a perspective view of a portion of another non-limitingcutting blade and bushing embodiment;

FIG. 95 is a cross-sectional view of a portion of the blade and bushingembodiment of FIG. 94 in a non-limiting surgical instrument embodiment;

FIG. 96 is a partial perspective view of a portion of a non-limitingblade and outer sheath embodiment;

FIG. 97 is a cross-sectional view of the blade and outer sheatharrangement of FIG. 96;

FIG. 98 is a partial rear perspective view of a portion of the outersheath and blade arrangement of FIG. 97;

FIG. 99 is a partial rear perspective view of a portion of anothernon-limiting outer sheath and blade embodiment;

FIG. 100 is a partial perspective view of another non-limiting outersheath embodiment;

FIG. 101 is a cross-sectional end view of the outer sheath embodiment ofFIG. 100 supporting a cutting blade embodiment therein; and

FIG. 102 is a perspective view of a portion of another non-limitingblade embodiment.

DESCRIPTION

The owner of the present application also owns the following U.S. patentapplications that were filed on even date herewith and which are hereinincorporated by reference in their respective entireties:

-   U.S. patent application Ser. No. 12/703,860, entitled ULTRASONICALLY    POWERED SURGICAL INSTRUMENTS WITH ROTATING CUTTING IMPLEMENT;-   U.S. patent application Ser. No. 12/703,866, entitled SEAL    ARRANGEMENTS FOR ULTRASONICALLY POWERED SURGICAL INSTRUMENTS;-   U.S. patent application Ser. No. 12/703,870, entitled ULTRASONIC    SURGICAL INSTRUMENTS WITH ROTATABLE BLADE AND HOLLOW SHEATH    ARRANGEMENTS;-   U.S. patent application Ser. No. 12/703,875, entitled ROTATABLE    CUTTING IMPLEMENT ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS;-   U.S. patent application Ser. No. 12/703,877, entitled ULTRASONIC    SURGICAL INSTRUMENTS WITH PARTIALLY ROTATING BLADE AND FIXED PAD    ARRANGEMENT;-   U.S. patent application Ser. No. 12/703,879, entitled DUAL PURPOSE    SURGICAL INSTRUMENT FOR CUTTING AND COAGULATING TISSUE;-   U.S. patent application Ser. No. 12/703,885, entitled OUTER SHEATH    AND BLADE ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS;-   U.S. patent application Ser. No. 12/703,893, entitled ULTRASONIC    SURGICAL INSTRUMENTS WITH MOVING CUTTING IMPLEMENT; and-   U.S. patent application Ser. No. 12/703,899, entitled ULTRASONIC    SURGICAL INSTRUMENT WITH COMB-LIKE TISSUE TRIMMING DEVICE.

Various embodiments are directed to apparatuses, systems, and methodsfor the treatment of tissue Numerous specific details are set forth toprovide a thorough understanding of the overall structure, function,manufacture, and use of the embodiments as described in thespecification and illustrated in the accompanying drawings. It will beunderstood by those skilled in the art, however, that the embodimentsmay be practiced without such specific details. In other instances,well-known operations, components, and elements have not been describedin detail so as not to obscure the embodiments described in thespecification. Those of ordinary skill in the art will understand thatthe embodiments described and illustrated herein are non-limitingexamples, and thus it can be appreciated that the specific structuraland functional details disclosed herein may be representative and do notnecessarily limit the scope of the embodiments, the scope of which isdefined solely by the appended claims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation.

Various embodiments are directed to improved ultrasonic surgical systemsand instruments configured for effecting tissue dissecting, cutting,and/or coagulation during surgical procedures as well as the cuttingimplements and sealing features employed thereby. In one embodiment, anultrasonic surgical instrument apparatus is configured for use in opensurgical procedures, but has applications in other types of surgery,such as laparoscopic, endoscopic, and robotic-assisted procedures.Versatile use is facilitated by selective use of ultrasonic energy andthe selective rotation of the cutting/coagulation implement.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

Surgical Systems

FIG. 1 illustrates in schematic form one non-limiting embodiment of asurgical system 10. The surgical system 10 may include a ultrasonicgenerator 12 and an ultrasonic surgical instrument assembly 100 that mayinclude a “self-contained” ultrasonic instrument 110. As will bediscussed in further detail below, the ultrasonic generator 12 may beconnected by a cable 14 to an ultrasonic transducer assembly 114 of theself-contained ultrasonic instrument 110 by a slip ring assembly 150located in a housing portion 102 of the surgical instrument assembly100. In one embodiment, the system 10 further includes a motor controlsystem 20 that includes a power supply 22 that is coupled to a controlmodule 24 by cable 23 to supply, for example, 24VDC thereto. The motorcontrol module 24 may comprise a control module manufactured by NationalInstruments of Austin, Tex. under Model No. NI cRIO-9073. However, othermotor control modules may be employed. The power supply 22 may comprisea power supply manufactured by National Instruments. However, otherpower supplies may be successfully employed. The power supply 22 may befurther coupled to a motor drive 26 by cable 25 to also supply 24VDCthereto. The motor drive 26 may comprise a motor drive manufactured byNational Instruments. Control module 24 may also be coupled to the motordrive 26 by cable 27 for supplying power thereto. A conventional footpedal 30 or other control switch arrangement may be attached to thecontrol module 24 by a cable 31. As will be discussed in further detailbelow, the ultrasonic surgical instrument 100 may include a motor 190that has an encoder 194 associated therewith. The motor 190 may comprisea motor manufactured by National Instruments under Model No.CTP12ELF10MAA00. The encoder 194 may comprise an encoder manufactured byU.S. Digital of Vancouver, Wash. under Model No. E2-500-197-I-D-D-B.However, other motors and encoders may be used. The encoder 194 may becoupled to the motor control module 24 by an encoder cable 32 and themotor 190 may be coupled to the motor drive 26 by cable 33. The surgicalsystem 10 may also include a computer 40 that may communicate byEthernet cable 42 with the motor control module 24.

As can also be seen in FIG. 1, in various embodiments, the motor controlsystem 20 is housed in an enclosure 21. To facilitate easy portabilityof the system, various components may be attached to the motor controlsystem 20 by removable cable connectors. For example, foot pedal switch30 may be attached to a detachable cable connector 37 by cable 35 tofacilitate quick attachment of the foot pedal to the control system 20.A/C power may be supplied to the power supply 22 by a conventionalplug/cable 50 that is attached to a detachable cable connector 54 thatis attached to cable 52. The computer 40 may have a cable 60 that isattached to detachable cable connector 62 that is coupled to cable 42.The encoder 194 may have an encoder cable 70 that is attached to adetachable connector 72. Likewise, the motor 190 may have a cable 74that is attached to the detachable connector 72. The detachableconnector 72 may be attached to the control module 24 by cable 32 andthe connector 72 may be attached to the motor drive 26 by cable 33.Thus, cable connector 72 serves to couple the encoder 194 to the controlmodule 24 and the motor 190 to the motor drive 26. The cables 70 and 74may be housed in a common sheath 76.

In an alternative embodiment, the ultrasonic generator 12 and thecontrol system 20 may be housed in the same enclosure 105. See FIG. 1A.In yet another embodiment, the ultrasonic generator 12 may electricallycommunicate with the motor control system 20 by a jumper cable 107. Sucharrangement may share a data link as well as a common means forsupplying power (cord 50). See FIG. 1B.

In various embodiments, the ultrasonic generator 12 may include anultrasonic generator module 13 and a signal generator module 15. SeeFIG. 1. The ultrasonic generator module 13 and/or the signal generatormodule 15 each may be integrated with the ultrasonic generator 12 or maybe provided as a separate circuit module electrically coupled to theultrasonic generator 12 (shown in phantom to illustrate this option). Inone embodiment, the signal generator module 15 may be formed integrallywith the ultrasonic generator module 13. The ultrasonic generator 12 maycomprise an input device 17 located on a front panel of the generator 12console. The input device 17 may comprise any suitable device thatgenerates signals suitable for programming the operation of thegenerator 12 in a known manner. Still with reference to FIG. 1, thecable 14 may comprise multiple electrical conductors for the applicationof electrical energy to positive (+) and negative (−) electrodes of anultrasonic transducer assembly 114 as will be discussed in furtherdetail below.

Various forms of ultrasonic generators, ultrasonic generator modules andsignal generator modules are known. For example, such devices aredisclosed in commonly owned U.S. patent application Ser. No. 12/503,770,entitled Rotating Transducer Mount For Ultrasonic Surgical Instruments,filed Jul. 15, 2007, which is herein incorporated by reference in itsentirety. Other such devices are disclosed in one or more of thefollowing U.S. patents, all of which are incorporated by referenceherein: U.S. Pat. No. 6,480,796 (Method for Improving the Start Up of anUltrasonic System Under Zero Load Conditions); U.S. Pat. No. 6,537,291(Method for Detecting a Loose Blade in a Handle Connected to anUltrasonic Surgical System); U.S. Pat. No. 6,626,926 (Method for Drivingan Ultrasonic System to Improve Acquisition of Blade Resonance Frequencyat Startup); U.S. Pat. No. 6,633,234 (Method for Detecting BladeBreakage Using Rate and/or Impedance Information); U.S. Pat. No.6,662,127 (Method for Detecting Presence of a Blade in an UltrasonicSystem); U.S. Pat. No. 6,678,621 (Output Displacement Control UsingPhase Margin in an Ultrasonic Surgical Handle); U.S. Pat. No. 6,679,899(Method for Detecting Transverse Vibrations in an Ultrasonic Handle);U.S. Pat. No. 6,908,472 (Apparatus and Method for Altering GeneratorFunctions in an Ultrasonic Surgical System); U.S. Pat. No. 6,977,495(Detection Circuitry for Surgical Handpiece System); U.S. Pat. No.7,077,853 (Method for Calculating Transducer Capacitance to DetermineTransducer Temperature); U.S. Pat. No. 7,179,271 (Method for Driving anUltrasonic System to Improve Acquisition of Blade Resonance Frequency atStartup); and U.S. Pat. No. 7,273,483 (Apparatus and Method for AlertingGenerator Function in an Ultrasonic Surgical System).

Surgical Instruments

As can be seen in FIG. 2, an ultrasonic surgical instrument handpiece100 may comprise a housing 102 that houses the motor 190, the encoder194, the slip ring assembly 150 and the self-contained ultrasonicsurgical instrument 110. The housing 102 may be provided in two or moreparts that are attached together by fasteners such as screws, snapfeatures, etc. and may be fabricated from, for example, polycarbonatematerial. The motor 190 may comprise, for example, a stepper motormanufactured by National Instruments under Model No. CTP12ELF10MAA00.However other motors may be employed to effectuate, for example, “gross”rotational motion of the self-contained ultrasonic surgical instrument110 relative to the housing 102 on the order of 1-6000 rpm. The encoder194 converts the mechanical rotation of the motor shaft 192 intoelectrical pulses that provide speed and other motor control informationto the control module 24.

The self-contained ultrasonic surgical instrument 110 may comprise asurgical instrument that is manufactured and sold by EthiconEndo-Surgery under Model No. HP054. However, other ultrasonicinstruments may be successfully employed. It will be understood that theterm “self-contained” as used herein means that the ultrasonic surgicalinstrument may be effectively used as an ultrasonic surgical instrumenton its own, apart from use with the surgical instrument 100. Asillustrated in more detail in FIG. 3, the ultrasonic surgical instrument110 includes a housing 112 that supports a piezoelectric ultrasonictransducer assembly 114 for converting electrical energy to mechanicalenergy that results in longitudinal vibrational motion of the ends ofthe transducer assembly 114. The ultrasonic transducer assembly 114 maycomprise a stack of ceramic piezoelectric elements with a motion nullpoint located at some point along the stack. The ultrasonic transducerassembly 114 may be mounted between two cylinders 116 and 118. Inaddition, a cylinder 120 may be attached to cylinder 118, which in turnis mounted to the housing at another motion null point 122. A horn 124may also be attached at the null point on one side and to a coupler 126on the other side. A blade 200 may be fixed to the coupler 126. As aresult, the blade 200 will vibrate in the longitudinal direction at anultrasonic frequency rate with the ultrasonic transducer assembly 114.The ends of the ultrasonic transducer assembly 114 achieve maximummotion with a portion of the stack constituting a motionless node, whenthe ultrasonic transducer assembly 114 is driven at maximum current atthe transducer's resonant frequency. However, the current providing themaximum motion will vary with each instrument and is a value stored inthe non-volatile memory of the instrument so the system can use it.

The parts of the ultrasonic instrument 110 may be designed such that thecombination will oscillate at the same resonant frequency. Inparticular, the elements may be tuned such that the resulting length ofeach such element is one-half wavelength or a multiple thereof.Longitudinal back and forth motion is amplified as the diameter closerto the blade 200 of the acoustical mounting horn 124 decreases. Thus,the horn 124 as well as the blade/coupler may be shaped and dimensionedso as to amplify blade motion and provide ultrasonic vibration inresonance with the rest of the acoustic system, which produces themaximum back and forth motion of the end of the acoustical mounting horn124 close to the blade 200. A motion from 20 to 25 microns at theultrasonic transducer assembly 114 may be amplified by the horn 124 intoblade movement of about 40 to 100 microns.

When power is applied to the ultrasonic instrument 110 by operation ofthe foot pedal 30 or other switch arrangement, the control system 20may, for example, cause the blade 200 to vibrate longitudinally atapproximately 55.5 kHz, and the amount of longitudinal movement willvary proportionately with the amount of driving power (current) applied,as adjustably selected by the user. When relatively high cutting poweris applied, the blade 200 may be designed to move longitudinally in therange of about 40 to 100 microns at the ultrasonic vibrational rate.Such ultrasonic vibration of the blade 200 will generate heat as theblade contacts tissue, i.e., the acceleration of the blade 200 throughthe tissue converts the mechanical energy of the moving blade 200 tothermal energy in a very narrow and localized area. This localized heatcreates a narrow zone of coagulation, which will reduce or eliminatebleeding in small vessels, such as those less than one millimeter indiameter. The cutting efficiency of the blade 200, as well as the degreeof hemostasis, will vary with the level of driving power applied, thecutting rate or force applied by the surgeon to the blade, the nature ofthe tissue type and the vascularity of the tissue.

As can be seen in FIG. 2, the ultrasonic instrument 110 is supportedwithin the housing 102 by a tailpiece drive adapter 130 and a distalhandpiece adapter 134. The tailpiece drive adapter 130 is rotatablysupported within housing 102 by a proximal bearing 132 and isnon-rotatably coupled to the output shaft 192 of the motor 190. See FIG.2. The tailpiece drive adapter 130 may be pressed onto the housing 112of the ultrasonic instrument 110 or, for example, be attached to thehousing 112 by setscrews or adhesive. The distal handpiece adapter 134may be pressed onto a distal end 113 of the handpiece housing 112 or beotherwise attached thereto by set screws or adhesive. The distalhandpiece adapter 134 is rotatably supported in the housing 102 by adistal bearing 136 that is mounted within housing 102.

When power is applied to motor 190, motor 190 applies a “grossrotational motion” to the handpiece 110 to cause the ultrasonic surgicalinstrument 110 and blade 200 to rotate about central axis A-A. As usedherein, the term “gross rotational motion” is to be distinguished fromthat “torsional ultrasonic motion” that may be achieved when employing anon-homogeneous formed ultrasonic blade. The term “gross rotationalmotion” instead encompasses rotational motion that is not solelygenerated by operation of the ultrasonic transducer assembly 114.

To provide the ultrasonic instrument 110 with power from the ultrasonicgenerator 12, a slip ring, assembly 150 may be employed. As can be seenin FIG. 2, conductors 151, 152 are coupled to the ultrasonic transducerassembly 114 and extend through a hollow stem portion 132 of the tailpiece drive adapter 130. The hollow stem portion 132 is attached to thedrive shaft 192 of the motor 190 and is free to rotate within the slipring assembly 150. A first inner contact 154 is attached to the hollowstem portion 132 for rotational travel therewith about axis A-A. Thefirst inner contact 154 is positioned for rotational contact with afixed outer contact 156 within the slip ring assembly 150. The contacts154, 156 may be provided in the form of concentrically arranged rings.Conductors 157, 158 are coupled to the fixed outer contact 156 and formgenerator cable 14. Conductors 191 and 193 are attached to the motor andform motor cable 74 and conductors 195, 197 are attached to encoder 194and form encoder cable 70. Rotation of the motor shaft 192 results inthe rotation of the tailpiece drive adapter 130 and the ultrasonicinstrument 110 attached thereto about axis A-A. Rotation of the motordrive shaft 192 also results in the rotation of the inner contact 154.Ultrasonic signals from the ultrasonic generator 12 are transferred tothe inner contact 154 by virtue of contact or “electrical communication”between the inner contact 154 and the outer contact 156. Those signalsare transmitted to the ultrasonic transducer assembly 114 by conductors151, 152. In other alternative embodiments, the slip ring assembly mayemploy use of conventional pogo pins that engage concentric ringcontacts. Other slip ring arrangements could also be employed.

Various embodiments also include a distal nosepiece 160 that may beremovably attached to the distal end 103 of the housing 102 by fasteners161. See FIG. 5. One or more shim members 162 may be positioned betweenthe distal end 103 and the nosepiece 160 to facilitate coaxialattachment between the housing 102 and the nosepiece 160. The nosepiece160 may be fabricated from, for example, stainless steel orpolycarbonate. In various embodiments, the distal end 202 of the blade200 extends through a hollow coupler segment 210 that is journaledwithin an inner sheath seal 212. Inner sheath seal 212 may comprise, forexample, polytetrafluoroethylene (PTFE″), and serve to establish asubstantially fluid-tight and/or airtight seal between the couplersegment 210 and the nosepiece 160. Also in the embodiment of FIG. 4, aninner sheath 220 may be attached to the hollow coupler segment 210 by,for example, welding or the hollow coupler segment 210 may comprise anintegral portion of the inner sheath 220. In one embodiment, a bladepin/torquing member 216 may extend transversely through the blade member200 and the hollow coupler segment 210 to facilitate movement of theinner sheath 220 with the blade member 200. One or more vented siliconebushings 214 may be journaled around the blade 200 to acousticallyisolate the blade 200 from the inner sheath 220. The blade member 200may have a proximal end 201 that is internally threaded and adapted toremovably engage a threaded portion of the coupler 126. To facilitatetightening of the blade 200 to the coupler 126, a tightening hole 108(FIG. 2) may be provided through the housing 102 to enable a tool (e.g.,Allen wrench) to be inserted therethrough into a hole 131 in the tailpiece drive adapter 130 to prevent the rotation of the ultrasonicsurgical instrument 110 and coupler 126 attached thereto. Once the blade200 has been screwed onto the coupler 126, the user may remove the Allenwrench or other tool from holes 108, 131 and insert a threaded plug (notshown) into hole 108 to prevent fluids/debris from entering the housing102 therethrough.

Also in various embodiments, an outer sheath 230 may be coaxiallyaligned with the inner sheath 220 and blade member 200 and be attachedto a distal end 163 of nosepiece 160 by, for example, welding, brazing,overmolding or pressfit. As can be seen in FIG. 4, a suction port 240may be attached to the nosepiece 160 to communicate with the hollowouter sheath 230. A flexible tube 242 may be attached to the suctionport 240 and communicate with a collection receptacle 243 that iscoupled to a source of vacuum, generally depicted as 244. Thus, theouter sheath 230 forms a suction path extending around the inner sheath220 that begins at a distal tip of the outer sheath 230 and goes outthrough the suction port 240. Those of ordinary skill in the art willappreciate that alternate suction paths are also possible. In addition,in alternative embodiments, the inner sheath 220 is omitted.

Various embodiments of the surgical system 10 provide the ability toselectively apply ultrasonic axial motion to the blade 200 and grossrotational motion to the blade 200 as well. If desired, the clinicianmay simply activate the ultrasonic transducer assembly 114 withoutactivating the motor 190. In such cases, the instrument 100 may be usedin ultrasonic mode simply as an ultrasonic instrument. Frequency rangesfor longitudinal ultrasonic motion may be on the order of, for example,30-80 kHz. Similarly, the clinician may desire to active the motor 190without activating the ultrasonic transducer assembly 114. Thus, grossrotational motion will be applied to the blade 200 in the rotation mode,without the application of longitudinal ultrasonic motion thereto. Grossrotational speeds may be, for example, on the order of 1-6000 rpm. Inother applications, the clinician may desire to use the instrument 100in the ultrasonics and rotational modes wherein the blade 200 willexperience longitudinal ultrasonic motion from the transducer assembly114 and gross rotational motion from the motor. Oscillatory motion of,for example, 2 to 10 revolutions per cycle (720 to 3600 degrees) orcontinuous unidirectional rotation may be achieved. Those of ordinaryskill in the art will readily appreciate that various embodiments of thesurgical system 10 may be affectively employed in connection witharthroscopic as well as other surgical applications.

At least one non-limiting embodiment may further include a controlarrangement 170 on the housing 102. See FIG. 2. The control arrangement170 may communicate with the control module 24 by multi-conductor cable171. The control arrangement 170 may include a first button 172 foractivating/deactivating a “dual” mode that includes the “ultrasonicmode” and “rotational mode”. In such arrangements, the control module 24may be pre-programmed to provide a pre-set amount of gross rotationalmotion to the blade 200. The control arrangement 170 may further includea second button 174 for activating/deactivating the rotational modewithout activating the ultrasonics mode to thereby cut withouthemostasis. The control arrangement 170 may also include a third button176 for activating/deactivating a “coagulation mode” wherein the motor190 drives to a pre-set rotational orientation and then “parks” ordeactivates, thereby exposing the ultrasonic blade surface at the distalend of the outer sheath 240 as will be discussed in further detailbelow. Also in this mode, the ultrasonic transducer assembly 114 may bepowered to provide spot coagulation or in an alternative embodiment, theclinician may simply activate a spot coagulation button 77 whichactivates the ultrasonic transducer assembly 114 for a preset timeperiod of, for example, five seconds. The control arrangement mayfurther include a button 178 to switch between ultrasonics androtational modes. In accordance with various non-limiting embodiments,any combinations of the aforementioned functions/modes may be combinedand controlled by one or more buttons without departing from the spiritand scope of the various non-limiting embodiments disclosed herein aswell as their equivalent structures.

Those of ordinary skill in the art will understand that the housingmember 102 and the mounting adapters 130 and 134 may be configured tooperably support various different types and shapes of ultrasonichandpieces therein that may be independently used apart from thesurgical instrument 100. Thus, the control system 20 and instrument 100may be provided in “kit form” without the ultrasonic handpiece 110 toenable the purchaser to install their existing ultrasonic handpiecetherein without departing from the spirit and scope of the variousnon-limiting embodiments disclosed herein as well as their respectiveequivalent structures.

FIGS. 6 and 7 illustrate another surgical instrument 300 wherein likenumbers previously used to describe the various embodiments discussedabove are used to designate like components. In these embodiments, thesurgical instrument 300 includes a housing 302 that houses a transducerassembly 314 that is attached to an ultrasonic horn 324. The ultrasonichorn 324 may be coupled to the proximal end 201 of the blade 200 in themanner described above. The ultrasonic horn 324 may be rotatablysupported within the housing 302 by a distal bearing 336. A nosepiece160 may be attached to the housing 302 by fasteners 161 in the mannerdescribed above.

In this embodiment, the ultrasonic transducer assembly 314 has magnets316 embedded or otherwise attached thereto to form an integral motorrotor, generally designated as 320. A motor stator ring 330 is mountedwithin the housing 302 as shown. Conductors 332, 334 are attached to themotor stator ring 330 and pass through the common sheath 76 to beattached to the motor cable 33 in the control system 20 as describedabove. A hollow shaft 340 extends through the motor rotor 320 to form apassage for conductors 151, 152. Conductors 151, 152 are coupled to theultrasonic transducer assembly 314 and an inner contact 154. The innercontact 154 is attached to a portion of the hollow shaft 340 thatrotatably extends into a slip ring assembly 150 that is also supportedwithin the housing 302. The hollow shaft 340 is rotatably supportedwithin the housing 302 by a proximal bearing 342. The slip ring assembly150 is fixed (i.e., non-rotatable) within the housing 302 and includes afixed outer contact 156 that is coupled to conductors 157, 158 that formgenerator cable 14 as was described above. When power is supplied to themotor stator 330, the rotor 320 and the integral ultrasonic transducer314 are caused to rotate about axis A-A. Ultrasonic signals from theultrasonic generator 12 are transferred to the inner contact 154 byvirtue of rotating contact or electrical communication between the innercontact 154 and the outer contact 156. Those signals are transmitted tothe ultrasonic transducer assembly 314 by conductors 151, 152. Thesurgical instrument 300 may include a control arrangement of the typedescribed above and be used in the various modes described above. Asuction may be applied between the blade 200 and outer sheath 230through port 240. A collection receptacle 243 and source of suction 240may be attached to the port 240 by tube 242. The distal end of the bladeis exposed through a window in the distal end of the outer sheath 230 toexpose the blade to tissue as will be further discussed below.

FIG. 8 illustrates another surgical instrument 400 wherein like numberspreviously used to describe the various embodiments discussed above areused to designate like components. In these embodiments, the surgicalinstrument 400 includes a housing 302 that houses an ultrasonictransducer assembly 314 that is attached to an ultrasonic horn 324. Theultrasonic horn 324 may be coupled to the proximal end 201 of the blade200 in the manner described above. The ultrasonic horn 324 may berotatably supported within the housing 302 by a distal bearing 336. Anosepiece 160 may be attached to the housing 302 in the manner describedabove.

In this embodiment, a brushed motor 410 is integrally attached to theultrasonic transducer assembly 314. As used herein “integrally attached”means directly attached to or otherwise formed with the ultrasonictransducer assembly 314 for travel therewith. The term “integrallyattached” as used with reference to the attachment of the brushed motor410 to the ultrasonic transducer assembly 314 does not encompass thoseconfigurations wherein the ultrasonic transducer assembly is attached tothe motor via a driven shaft arrangement. Also in this embodiment,magnets 426 are provided in a stator ring 420 that is fixed within thehousing 302. Conductors 432, 434 extend through a hollow shaft 340 thatis attached to the brushed motor 410. The hollow shaft 340 is rotatablysupported within the housing 302 by proximal bearing 342. The motorconductor 432 is attached to a first inner motor contact 436 and themotor conductor 434 is attached to a second inner motor contact 438. Thefirst and second inner motor contacts 436, 438 are supported on theportion of the hollow shaft 340 that extends into a slip ring assembly,generally designated as 450. The slip ring assembly 450 is fixed (i.e.,non-rotatable) within the housing 302 and includes a first outer motorcontact 440 that is coupled to conductor 441 and a second outer motorcontact 442 that is coupled to conductor 443. The conductors 441, 443form motor cable 74 as was described above. When the clinician desiresto apply gross rotational motion to the ultrasonic transducer assembly314 and ultimately to the blade 200, the clinician causes power to besupplied to the brushed motor 410 from the motor drive 26.

Also in this embodiment, conductors 151, 152 are attached to theultrasonic transducer assembly 314 and extend through the hollow shaft340 to be coupled to inner transducer contact 154 that is attached tothe hollow shaft 340. The slip ring assembly 450 includes a fixed outertransducer contact 156 that is coupled to conductors 157, 158 that formgenerator cable 14 as was described above. When power is supplied to thebrushed motor 410, the motor 410, ultrasonic transducer assembly 314,and motor shaft 340 are caused to rotate about axis A-A. Ultrasonicsignals from the ultrasonic generator 12 are transferred to the innercontact 154 by virtue of rotational sliding contact or electricalcommunication between the inner contact 154 and the outer contact 156.Those signals are transmitted to the ultrasonic transducer assembly 314by conductors 151, 152. The surgical instrument 400 may include acontrol arrangement of the type described above and be used in thevarious modes described above. It will be understood that the instrument400 may be used in rotation mode, ultrasonic mode, rotation andultrasonic mode (“duel mode”) or coagulation mode as described above. Asuction may be applied between the blade 200 and outer sheath 230through port 240. A collection receptacle 243 and source of suction 240may be attached to the port 240 by tube 242. The distal end of the bladeis exposed through a window in the distal end of the outer sheath 230 toexpose the blade to tissue as will be further discussed below.

FIGS. 9-13 illustrate another surgical instrument 500 wherein likenumbers previously used to describe the various embodiments discussedabove are used to designate like components. In these embodiments, thesurgical instrument 500 includes a housing 302 that houses a transducerassembly 530 that is attached to an ultrasonic horn 324. The ultrasonichorn 324 may be coupled to the proximal end 201 of the blade 200 in themanner described above. The ultrasonic horn 324 may be rotatablysupported within the housing 302 by a distal bearing 336. A nosepiece160 may be attached to the housing 302 in the manner described above.

This embodiment includes a motor 510 that may comprise a stepper motorof the type and construction described above and may have an encoderportion associated therewith that communicates with the control module24 as was described above. The motor 510 may receive power from themotor drive 26 through conductors 511, 512 that comprise motor cable 74that extends through the common sheath 76. The motor 510 has a hollowmotor shaft 520 attached thereto that extends through a slip ringassembly 150. The hollow drive shaft 520 is rotatably supported withinthe housing 302 by a proximal bearing 342. The slip ring assembly 150 isfixed (i.e., non-rotatable) within the housing 302 and includes a fixedouter contact 156 that is coupled to conductors 157, 158 that formgenerator cable 14 as was described above. An inner contact 154 ismounted on the hollow drive shaft 520 and is in electrical contact orcommunication with outer contact 156. Conductors 151, 152 are attachedto the inner contact 154 and extend through the hollow drive shaft 520to be coupled to the ultrasonic transducer assembly 530.

In various embodiments, to facilitate ease of assembly and also toacoustically isolate the motor from the ultrasonic transducer assembly530, the hollow drive shaft 520 may be detachably coupled to theultrasonic transducer stack 530 by a coupling assembly, generallydesignated as 540. As can be seen in FIGS. 9, 11, and 12, the couplingassembly 540 may include a thin plate member 542 that is attached to adistal end 521 of the hollow drive shaft 520. The thin plate member 542may be fabricated from a material that has a relatively low stiffness inthe axial direction and a high stiffness in rotation. See FIG. 12. Forexample, the thin plate member 542 may be fabricated from 0.008 inchthick Aluminum 7075-T651 and be attached to the distal end 521 of thehollow drive shaft 520 by, for example, by a press fit or brazing. Thecoupling assembly 540 may further include a proximal end mass or flangeportion 531 of the ultrasonic transducer assembly 530. The proximal endmass 531 may comprise, for example, a flange manufactured from stainlesssteel which is attached to the ultrasonic transducer assembly 530 by,for example, a bolted or other connection. As can be seen in FIG. 11,the end mass 531 has a hole 532 sized to receive the thin plate member542 therein. In various embodiments, the thin plate member 542 may besized to be pressed into the hole 532 such that rotation of the thinplate member 542 about axis A-A will cause the ultrasonic transducerassembly 530 to rotate about axis A-A. In other embodiments, a separatefastener plate (not shown) or snap rings (not shown) or snap features(not shown) may be provided to retain the thin plate member 542 innon-rotatable engagement with the end mass 531 of the ultrasonictransducer assembly 530. Such arrangements serve to minimize thetransmission of acoustic vibrations to the motor from the ultrasonictransducer assembly.

FIGS. 14 and 15 illustrate an alternative thin plate member 542′ thatmay be employed. In this embodiment, the thin plate member 542′ has aplurality of radial notches 544 provided therein to form radial tabs546. The hole 532 would be formed with notches (not shown) toaccommodate the radial tabs 546 therein. Such arrangement may reduce themoment force applied to the shaft 520. By employing the thin platemembers 542, 542′ the amount of acoustic vibrations that are transferredfrom the ultrasonic transducer assembly 530 to the drive shaft 520 maybe minimized.

When power is supplied to the motor 510, the drive shaft 520 rotatesbout axis A-A which also causes the transducer assembly 530 to rotateabout axis A-A. When the clinician desires to power the ultrasonictransducer assembly 530, power is supplied form the ultrasonic generator12 to the fixed contact 156 in the slip ring assembly 150. Power istransmitted to the ultrasonic transducer assembly 530 by virtue ofrotational sliding contact or electrical communication between the innercontact 154 and the outer contact 156. Those signals are transmitted tothe ultrasonic transducer assembly 530 by conductors 151, 152. Thesurgical instrument 500 may include a control arrangement of the typedescribed above and be used in the various modes described above. Itwill be understood that the instrument 400 may be used in rotation mode,ultrasonic mode, rotation and ultrasonic mode (“duel mode”) orcoagulation mode as described above. A suction may be applied betweenthe blade 200 and outer sheath 230 through port 240. A collectionreceptacle 243 and source of suction 240 may be attached to the port 240by tube 242. The distal end of the blade is exposed through a window inthe distal end of the outer sheath 230 to expose the blade to tissue aswill be further discussed below.

FIG. 16 illustrates another surgical instrument 600 wherein like numberspreviously used to describe the various embodiments discussed above areused to designate like components. In these embodiments, the surgicalinstrument 600 includes a housing 302 that houses a transducer assembly314 that is attached to an ultrasonic horn 324. In this embodiment, thetransducer assembly 314 and the ultrasonic horn 324 are attached to aPZT housing 602 that is rotatably supported within the housing 302 by adistal bearing 336. The ultrasonic horn 324 may be coupled to theproximal end of the blade 200 in the manner described above. A nosepiece160 may be attached to the housing 302 by fasteners 161 in the mannerdescribed above.

This embodiment includes a motor 510 that may comprise a stepper motorof the type and construction described above. The motor 510 may have anencoder associated therewith that communicates with the control module24 (FIG. 1) as was described above. The motor 510 may receive power fromthe motor drive 26 (FIG. 1) through conductors 511, 512 that comprisemotor cable 74 that extends through the common sheath 76. The motor 510has a hollow motor shaft 520 attached thereto that extends through aslip ring assembly 150. The hollow drive shaft 520 is rotatablysupported within the housing 302 by a proximal bearing 342.

The slip ring assembly 150 is fixed (i.e., non-rotatable) within thehousing 302 and includes a fixed outer contact 156 that is coupled toconductors 157, 158 that form generator cable 14 as was described above.An inner contact 154 is mounted on the rotatable hollow drive shaft 520and is in electrical contact or communication with outer contact 156.Conductors 151, 152 are attached to the inner contact 154 and extendthrough the hollow drive shaft 520 to be coupled to the ultrasonictransducer assembly 314. In various embodiments, to facilitate ease ofassembly and also acoustically isolate the motor 510 from the ultrasonictransducer assembly 314, the hollow drive shaft 520 may be detachablycoupled to the PZT housing 602 by a coupling assembly, generallydesignated as 540. The coupling assembly 540 may include a thin platemember 542 that is attached to a distal end 521 of the hollow driveshaft 520. As discussed above, the thin plate member 542 may befabricated from a material that has a relatively low stiffness in theaxial direction and a high stiffness in rotation. The PZT housing 602has a proximal end portion 604 that has a hole 603 sized to receive thethin plate member 542 therein. In various embodiments, the thin platemember 542 may be sized to be pressed into the hole 603 such thatrotation of the thin plate member 542 about axis A-A will cause the PZThousing 602 and ultrasonic transducer assembly 314 and ultrasonic horn324 to rotate about axis A-A. In other embodiments, a separate fastenerplate (not shown) or snap rings (not shown) or snap features (not shown)may be provided to retain the thin plate member 542 in non-rotatableengagement with the proximal end portion 604 of the PZT housing 602.This embodiment could also employ the thin plate member 542′ as wasdiscussed above.

When power is supplied to the motor 510, the drive shaft 520 rotatesabout axis A-A which also causes the PZT housing 602 and ultrasonictransducer assembly 314 to rotate about axis A-A. When the cliniciandesires to power the ultrasonic transducer assembly 314, power issupplied from the ultrasonic generator 12 to the fixed contact 156 inthe slip ring assembly 150. Power is transmitted to the ultrasonictransducer assembly 314 by virtue of rotational sliding contact orelectrical communication between the inner contact 154 and the outercontact 156. Those signals are transmitted to the ultrasonic transducerassembly 314 by conductors 151, 152. The surgical instrument 500 mayinclude a control arrangement of the type described above and be used inthe various modes described above. It will be understood that theinstrument 400 may be used in rotation mode, ultrasonic mode, rotationand ultrasonic mode (“duel mode”) or coagulation mode as describedabove. A suction may be applied between the blade 200 and outer sheath230 through port 240. A collection receptacle 243 and source of suction240 may be attached to the port 240 by tube 242. The distal end of theblade is exposed through a window in the distal end of the outer sheath230 to expose the blade to tissue as will be further discussed below.

In an effort to reduce the overall size of the housing 302 employed ineach of the instruments 300, 400, 500, and 600, the ultrasonictransducer assemblies employed in each of those respective instrumentscould be replaced with a half wave transducer that is physically shorterin length.

Ultrasonic Blade and Sheath Embodiments

Current arthroscopic tools include punches, reciprocating shavers, andradio frequency (RF) powered devices. Mechanical devices such as punchesand shavers tend to create minimal tissue damage, but can sometimesleave behind ragged cut lines which are not desirable. RF powered bladescan leave behind smoother cut lines and also ablate large volumes ofsoft tissue. However, such devices can create more tissue damage thanpure mechanical instruments. The various non-limiting surgicalinstruments embodiments described above provide a host of advantagesover conventional RF powered surgical instruments as well asconventional mechanical shavers that employ a rotating tissue cuttingmember. As will be discussed in further detail below, additionaladvantages may be realized by employing the unique and novel blade andsheath configurations of various non-limiting embodiments.

FIGS. 17-21 illustrate one form of blade 200 and outer sheath 230 thatmay be employed in connection with the various surgical instrumentsdescribed above. As can be seen in those Figures, the blade 200 may havea distal end portion 700 and the outer sheath 230 may have a distal endportion 720. The blade 200 may be fabricated from, for example, titaniumand the outer sheath 230 may be fabricated from, for example, Poly etherether ketone (“PEEK”), Ultem®, or stainless steel. As was discussedabove, the blade 200 may have a waveguide or proximal end portion thatis configured to be threadably or otherwise attached to an ultrasonichorn 324 (FIGS. 6-10 and 16) in a known manner. The distal end portion700 of the blade 200 may have a curved tip portion 702 formed thereon.The curved tip 702 may have an arcuate top segment 704 that has acutting edge 706 formed on each lateral side 705. The cutting edges 706may terminate distally in a common, substantially pointed distal end708. The pointed distal end 708 may be relatively blunted or the pointeddistal end 708 may have a relatively sharpened point. As can be seen inFIG. 20, the pointed distal end 708 may curve inwardly to about thecentral axis A-A of the blade. As can be seen in FIG. 19, in variousembodiments, the cutting edges 706 may not intersect each other but maybe separated by a center portion 707. As can be seen in FIG. 20, theblade 200 may have a reduced neck portion 710 that protrudes distallyfrom a waveguide or proximal blade portion 712. A node 714 may beestablished at the area where the neck portion 710 protrudes from theproximal portion 712.

As can be seen in FIG. 17, the outer sheath 230 also has a distal endportion 720 that has a window or opening 722 formed therein to exposethe distal end portion 700 of the blade 200. As can be further seen inFIG. 17, the outer sheath 230 may comprise a hollow cylinder that has asubstantially blunted end 724. In various embodiments, the window 722extends for one half of the circular cross-section of the sheath 230.Such window configuration forms an arcuate ledge 725 that extends aroundthe blunted end 724. In various embodiments, the outer sheath 230 may befabricated from, for example, Poly ether ether ketone (“PEEK”), Ultem®,or stainless steel. To prevent metal-to-metal contact between thecutting edges 706 on the distal end portion 700 of the blade 200 and theledge 725, a polymer fender 726 may be attached by, for example,adhesive or a T-slot around the ledge 724. See FIG. 17. Fender 726 maybe fabricated from, for example, Teflon®, silicone or other reduced or“low friction” material. The fender 726 may be sized to produce aninterference fit of, for example, 0.005 inches with the cutting edges706 and the pointed distal end 708.

In use, as the blade 200 is rotated about axis A-A within the outersheath 230 and introduced to tissue, the tissue is drawn into the window722 by means of the suction applied between the inner sheath 220 (FIG.4), and the outer sheath 230 as was described above. The tissue drawninto the window 722 is then cut as the cutting edges 706 are rotatedpast the fender 726 and the cut tissue may pass between the inner sheath220 and outer sheath 230 and out through the suction port 240 (FIGS. 4,6-10, and 16) to the collection receptacle 243 (FIGS. 4, 6-10, and 16).

In another embodiment, an axial suction passage 730 may be providedthrough the neck portion 710 of the blade 200. See FIG. 20. The axialsuction passage 730 may communicate with a transverse suction passage732 in the area of node 714. Thus, the cut tissue may pass through thepassages 730, 732 and out between the inner sheath 220 and outer sheath230 and out through the suction port 240 (FIGS. 4, 6-10, and 16) to thecollection receptacle 243 (FIGS. 4, 6-10, and 16). FIG. 21 depicts analternative embodiment wherein two exit passages 734, 736 communicatewith the axial passage 730 and extend at an angle therefrom. In variousembodiments, the exit passages 734,736 may extend from the axial passage730 at an angle 738 of, for example, forty-five (45) degrees. Sucharrangement may serve to reduce impedance and power losses duringultrasonic activation which might have otherwise resulted from waterbeing drawn in through the window 722 in the outer sheath 230.

In use, the clinician may elect to rotate the blade 200 within the outersheath 230 without applying ultrasonic motion thereto. The clinician mayalso elect to apply ultrasonic motion to the rotating blade or theclinician may wish apply ultrasonic motion to a parked (non-rotating)blade to use the portion of the blade exposed in the window 722 tocoagulate tissue.

FIG. 22 illustrates use of blade 200 in connection with an outer sheath230 that has a distal end portion 750 that includes a distallyprotruding nose segment 752. In various embodiments, the nose segment752 may have an arcuate width “W” that comprises approximately ten (10)to thirty (30) percent of the circumference of the distal end portion750 of the outer sheath 230. The nose segment 752 may protrude distallyfrom the end of the distal end portion 750 of the sheath 230 a length“L” that may be approximately 0.25 inches, for example. In alternativeembodiments, a low friction fender or guard (not shown) may be appliedto the sides 753 of the nose segment 752 if desired. These embodimentsmay operate in a similar manner to the previous embodiment. However,this embodiment has the added ability to cut tissue with the exposedtip. As with the other embodiments, the clinician may apply grossrotational motion to the blade 200 without ultrasonic motion or withultrasonic motion. In another alternative method of use, the exposed tip708 and partially exposed cutting edges 706 may be used to cut tissuewhen the blade is not being rotated or vibrated.

FIGS. 23-24 illustrate another non-limiting blade and outer sheathembodiment. In this embodiment, the blade 200 has a distal end portion760 that is substantially similar to the distal end portion 700 of theblade configuration described above. However, the distal blade portion760 does not hook inwardly to the same degree such that the blade tip762 does not intersect the central axis A-A. See FIG. 24. As can be seenin FIG. 23, the window 722′ in the distal end portion 720 of the outersheath 230 does not extend the entire distance from an end wall 725 tothe blunt tip 724. Thus, in this embodiment, the blunt tip 724 comprisesa nose that extends more than 90° but less than 180° (i.e., angle “A” inFIG. 23A is greater than 90° but less than 180°).

FIGS. 25 and 26 depict another non-limiting blade embodiment. In thisembodiment, the blade 200′ may be substantially similar to blade 200 orany of the other blades described herein. In this embodiment, the distalend 700′ has a roughened upper surface 705′. Such roughened surface 705′creates higher friction forces between the distal end portion 700′ ofthe blade 200′ and the tissue to draw the tissue into the window 722′ inthe distal end portion 720 of the outer sheath 230 (FIG. 26). By pullingmore tissue into the window 722, the leading cutting edge 706′ of theblade 200′ may have a higher likelihood of cutting the tissue cleanly.In various embodiments, for example, the roughened surface may be formedby knurling or the upper surface may be coated with a hard material suchas diamond or the like

FIGS. 27-29 illustrate another non-limiting blade embodiment. In thisembodiment, the blade 200″ may be substantially similar to blade 200described herein. In this embodiment, the distal end 700″ has a seriesof radially extending cutting teeth 707 protruding outward from uppersurface 705″ for pulling and cutting tissue as the blade 200″ is rotatedwithin the outer sheath 230.

FIGS. 30, 31, and 32A-D illustrate another non-limiting blade and outersheath embodiment. During use of various instruments that employ arotatable blade within an outer sheath, it has been experienced that thetissue may get “kicked out” of the sheath window as the blade rotatestherein. This can lead to reduced cutting speeds as tissue is notadequately captured and held between the cutting edges. The blade 800 ofthis embodiment addresses such potential shortcomings.

As can be seen in FIG. 30, the blade 800 may be substantially the sameas blade 200 except for the differences noted herein. In particular, theblade 800 may include a neck portion 803 that that terminates in adistal end portion 810. The distal end portion 810 may have a somewhatcurved tip 812. A series of teeth 817 may be provided on at least onelateral side 813 or 815 of the distal end portion 810. In the embodimentdepicted in FIGS. 32A-D, teeth 817 and 819 are formed on lateral sides813, 815, respectively, of the distal end portion 810. The distal endportion 810 further has a somewhat domed top portion 821. In theembodiment shown in FIGS. 30-32D, the teeth 817 comprise relativelysharp points that define a series of arcuate openings 823 therebetween.Teeth 819 also comprise relatively sharp points that have a series ofarcuate openings 825 therebetween. As shown in FIG. 30, an axial suctionpassage 805 may be provided through the neck portion 803 of the blade800. The axial suction passage 805 may communicate with a transversesuction passage 807 in the area of node 808. Thus, the cut tissue maypass through the passages 805, 807 and out between the inner sheath (notshown) and outer sheath 850 and out through a suction port to acollection receptacle in the manner described hereinabove. Other suctionpath arrangements may also be successfully employed.

The outer sheath 850 may be substantially similar to the outer sheath230 described above and have a distal sheath tip 852 attached theretothat has a window or opening 854 formed therein to expose the distal endportion 810 of the blade 800. See FIG. 31. The outer sheath 850 maycomprise a hollow cylinder fabricated from for example, stainless steel.In various embodiments, the window 854 extends for approximately onehalf of the circular cross-section of the sheath 850 and forms a bladeopening 858 therein. The distal sheath tip 852 may be fabricated frommetal such as, for example, stainless steel such that a relatively sharpcutting edge 860 extends around the blade opening 858. For the purposeof explanation, the sharp cutting edge 860 has a first lateral cuttingedge portion 862 and a second lateral cutting edge portion 864.

FIGS. 32A-D illustrate a sequential rotation of the blade 800 within theouter sheath 850. Turning to FIG. 32A first, the blade 800 is shownbeing rotated in a counter clockwise “CCW” direction. As shown in thatFigure, the cutting teeth 817 on the first lateral side 813 of the blade800 are positioned to shear tissue (not shown) between the teeth 817 andthe first lateral cutting edge portion 862 of the cutting edge 860. Whenin that position, the arcuate openings 823 between the teeth 817 areexposed to collectively form a first lateral suction path 870 betweenthe blade 800 and the distal sheath tip 852 to enable the tissue to bedrawn therein by the suction being applied through the suction passage805 (FIG. 30). As the rotational sequence continues, the domed upperportion 821 of the blade 800 covers the opening 854 in the distal sheathtip 852 such that there are no exposed suction paths for tissue to enterinto the opening 854. As the blade continues through its rotation, FIG.32C illustrates that the arcuate openings 825 between teeth 819collectively form a second lateral suction path 872 between the secondlateral cutting edge portion 864 and the blade 800 to enable tissue tobe drawn therein. As the blade 800 continues to rotate in the CCWdirection, a third suction path 874 is exposed to enable tissue to befurther drawn into opening 854. Thus, such arrangement permits asequential opening of suction paths from one lateral side of the bladeopening 858 to the other to facilitate better tissue cutting. In use,the clinician may elect to rotate the blade 800 within the outer sheath850 without applying ultrasonic motion thereto. The clinician may alsoelect to apply ultrasonic motion to the rotating blade or the clinicianmay wish apply ultrasonic motion to a parked (non-rotating) blade to usethe portion of the blade exposed in the opening 854 to coagulate tissue.

FIGS. 33 and 34 illustrate another blade embodiment 880 that may besubstantially the same as blade 200 except for the differences notedbelow. In particular, the blade 880 may include a waveguide or proximalportion 882 that that terminates in a distal tissue cutting portion 884.The proximal portion 882 of the blade 880 may be configured to bethreadably or otherwise attached to an ultrasonic horn of any of thevarious embodiments discussed above. The distal tissue cutting portion884 may have opposed arcuate channels 886, 888 formed therein. The firstarcuate channel 886 may define a first cutting edge 890 and the secondarcuate channel 888 may define a second cutting edge 892. This bladeembodiment may be used in connection with any of the outer sheathconfigurations described above. In the depicted embodiment, hollow outersheath 900 is employed which may be similar to sheath 230 for exampleand include a distal sheath tip 901 that has rounded or blunted noseportion 902 and a window 904. The hollow outer sheath 900 may befabricated from, for example, stainless steel and the distal sheath tip901 may be fabricated from metal such as, for example, stainless steel.The window 904 forms an arcuate cutting edge 906 that cooperates withthe cutting edges 890, 892 on the blade 880 to shear off tissue as theblade 880 is rotated within the outer sheath 900 in the various mannersdescribed above. In at least one embodiment, the proximal portion 882 ofblade 880 may be sized relative to the hollow outer sheath 900 such thata clearance is provided therebetween to enable a suction to be appliedthereto in the manner described above, for example. As can be seen inFIG. 34, as the blade 880 rotates (represented by arrow “R”) the arcuatechannels 886, 886 define openings 894, 896 between the distal end 884 ofthe blade 880 and the walls of the distal sheath tip 901 to enabletissue to be drawn therein by the suction (represented by arrows “S”)applied to the area between the inner wall of the outer sheath 900 andthe neck 882 of the blade 800. It will also be appreciated that theblade 880 may be rotated in a counter clockwise or clockwise directionor be selectively oscillated between such rotational directions andstill effectively cut tissue drawn therein. FIG. 34A depicts analternative sheath tip embodiment 901′ that is fabricated from a metalmaterial such as, for example, stainless steel that has a series ofserrated cutting teeth 905′ formed on each cutting edge 890′, 892′.

FIG. 35 depicts another blade embodiment 910 that may be substantiallythe same as blade 200 except for the differences noted below. Inparticular, the blade 910 may include a waveguide or proximal portion912 that that terminates in a distal tissue cutting portion 914. Theproximal portion 912 of the blade 910 may be configured to be threadablyor otherwise attached to an ultrasonic horn of any of the variousembodiments discussed above. The distal tissue cutting portion 914 mayhave opposed channels 916 formed therein that cooperate to define afirst cutting edge 920 and a second cutting edge 922. This bladeembodiment may be used in connection with any of the various outersheath configurations described above and is designed to only rotate ina single direction “R” for tissue cutting purposes. As with theabove-described embodiment, the arcuate channels 916 define openingsbetween the tissue cutting portion 914 of the blade 910 and the innerwalls of the distal sheath tip to enable tissue to be drawn therein assuction is applied to the area between the proximal portion 912 an theinner wall of the outer sheath.

FIG. 36 illustrates another surgical instrument 2000 wherein likenumbers previously used to describe the various embodiments discussedabove are used to designate like components. In these embodiments, thesurgical instrument 2000 includes a housing 302 that houses anultrasonic transducer assembly 314 that is attached to an ultrasonichorn 324. In this embodiment, the ultrasonic transducer assembly 314 andthe ultrasonic horn 324 may be non-rotatably supported within thehousing 302 in a known manner. Electrical control signals may besupplied to the ultrasonic transducer assembly 314 from an ultrasonicgenerator 12 by conductors 151, 152. Activation of the ultrasonicgenerator 12 will cause the ultrasonic transducer assembly 314 to applyultrasonic motion to the ultrasonic horn 324. In this embodiment, ahollow outer sheath 2010 is coupled to the ultrasonic horn 324 forreceiving ultrasonic motion therefrom. For example, in variousembodiments, the outer sheath 2010 may be coupled to the ultrasonic horn324 by a threaded connection or other suitable fastening arrangement.

This embodiment includes a rotatable blade 2020 that is rotatablysupported within the outer sheath 2010 and is coupled to a motor 510supported within the housing 302. The motor 510 may, for example,comprise a stepper motor of the type and construction described above.The motor 510 may have an encoder associated therewith that communicateswith a control module 24 (FIG. 1) as was described above. The blade 2020may have a hollow distal portion 2022 and a solid proximal portion 2024.See FIG. 36A. The solid proximal portion 2024 may be attached to themotor drive shaft 520 by a threaded or other suitable connection. Themotor drive shaft 520 may be rotatably supported within the housing 302by a proximal bearing 342. When control signals are supplied to themotor 510, the drive shaft 520 rotates about axis A-A which also causesthe blade 2020 to rotate about axis A-A within the outer sheath 2010.

As can be further seen in FIG. 36A, the hollow outer sheath 2010 issupported within a hollow nosepiece 160 that has a suction port 240therein. A flexible tube 242 may be attached to the suction port 240 andcommunicate with a collection receptacle 243 that is coupled to a sourceof suction, generally depicted as 244. The hollow sheath 2010 may besupported within the nosepiece 160 by a proximal seal 2013 and a distalseal 2015 which are located on each side of the suction port 240 asshown in FIG. 36A and which serve to establish fluid tight sealstherebetween. The hollow sheath 2010 is provided with at least oneproximal sheath opening 2014 in registration with the suction port 240between the proximal seal 2013 and the distal seal 2015. In addition,the hollow distal portion 2022 of the blade 2020 is rotatably supportedwithin the hollow sheath 2010 by at least a proximal blade seal 2025 anda distal blade seal 2027. At least one blade discharge port 2028 may beprovided through the hollow portion 2022 of the blade 2020 between theproximal blade seal 2025 and the distal blade seal 2027 to dischargeinto the at least one proximal sheath opening 2014.

Also in various embodiments, a distal end portion 2011 of the hollowouter sheath is closed and at least one opening or window 2012 isprovided therein to expose a distal tissue cutting portion 2025 of theblade 2020. In at least one embodiment window 2012 comprises anelongated slot and the distal tissue cutting portion also comprises anelongated slot 2026 in the blade 2020 (FIGS. 37 and 38). Thus, suctionmay be applied from the suction source 244 into the hollow portion ofblade 2020 through the port 240, the proximal sheath opening 2014 andthe blade discharge port 2028. As the distal openings 2026, 2012coincide, tissue “T” may be drawn into the hollow distal portion 2022 ofblade 2020 as shown in FIG. 38. The severed portions of tissue “T” maypass through the hollow distal portion 2022 of blade 2020 and outthrough openings 2028, 2014 and into the collection receptacle 243.

In use, the clinician may activate the rotating blade 2020 to cut andevacuate tissue. When a bleeder is encountered, the clinician mayactivate the ultrasonic transducer assembly 314 to send ultrasonicmotions to the outer sheath 2010 for coagulation purposes. For example,spinal fusion surgeries require the removal of disc material due to avariety of disease states. Often times this material is toughened andrequires quite a bit of force with conventional instrumentation to breakup the disc and remove its fragments. Once the disc material is removed,the end plates must be scraped to reveal fresh surfaces to promotefusion of the plates to the cage. The plates must also be shaped toprovide a good fit with the type of cage being used. Conventionalinstrumentation generally requires high forces from the surgeon veryclose to critical structures. In other embodiments, the motor may becoupled to rotate the ultrasonic transducer assembly and the blade maybe attached to the ultrasonic transducer assembly as was described aboveso that the blade rotates and may have ultrasonic motion appliedthereto.

Use of the above-described surgical instrument 2000 may be particularlyadvantageous when performing, for example, a discectomy as shown inFIGS. 39 and 40. As can be seen in those drawings, the outer sheath 2010may be inserted into the disc “D”. The rotating blade 2020 may be usedto shave off small pieces of disc and suction them out. Such arrangementeliminates the need for repeated insertion/removal of surgical tools.The device may also be employed to prepare the vertebrae endplates. Inthe embodiment depicted in FIGS. 41-45, the rotatable cutting blade 2020has a series of serrated teeth 2021 formed on at least one side of thedistal opening 2026 to further assist with the cutting of tissue drawnin through the opening 2012 in the outer sheath 2010. Also in thisembodiment, a retractable safety shield 2040 is movably mounted on theouter sheath 2010 and is selectively movable from a closed positionsubstantially covering the opening 2012 in the outer sheath 2010 to anopen position exposing the opening 2012 (FIGS. 43 and 44). Sucharrangement covers the teeth 2021 on the blade 2020 during insertion andremoval of the outer sheath 2010 adjacent vital nerves and othercritical tissues. To facilitate movement of the safety sheath 2040 onthe outer sheath 2010, a thumb control tab 2042 (FIGS. 41 and 45) may beformed on the proximal end of the safety sheath 2040 to enable theclinician to apply sliding actuation forces thereto. In addition, invarious embodiments, a retainer protrusion 2044 may be formed on thesafety sheath 2040 to engage at least one detent or groove 2046 providedin the outer sheath 2010 to retain the safety sheath 2040 in acorresponding open or closed position. For example, one detent or groove2046 may correspond to a closed position (wherein the safety sheath 2040covers the opening 2012) and another detent or groove 2046′ maycorrespond to a partially opened position (wherein a portion of theopening 2012 is exposed) and another detent or groove 2046″ maycorrespond to a fully opened position (wherein the opening 2012 is fullyexposed).

FIGS. 46-51 illustrate a blade 940 that has a nearly straight distaltissue cutting portion 942. Such blade configuration may reducepotential impedance and power increases when the blade 940 is used in anaqueous environment when compared to the impedance and powerrequirements of various other blade configurations when used in thatenvironment. That is, such relatively straighter blade designs mayrequire less power to operate in an aqueous environment. The blade 940may have a round or blunted distal end 944 and a groove 946 that formscutting edges 947, 948 for cutting tissue when the blade 940 is used inconnection with an outer sheath 230 as described above. The groove mayhave a length “L” of, for example, one (1) inch. The blade 942 may alsohave a suction passage 730 of the type and construction described above.As shown in FIG. 47, a low friction fender or pad 726 of the type andconstruction described above may be employed around the exposed distalend portion 720 of the outer sheath 230. FIGS. 48-51 depict alternativecross-sectional shapes of a blade 940 where differently shaped grooves946 are employed.

FIGS. 52-55 depict another non-limiting blade and sheath embodiment.This embodiment employs a hollow outer sheath 950 that may be attachedto the nosepiece or the ultrasonic transducer assembly of any of thesurgical instruments described above by any suitable fastening method orconnection arrangement. As can be seen in FIG. 55, the outer sheath 950has a closed rounded or blunted nose portion 952 and an elongatedrectangular-shaped window or opening 954. In one embodiment, forexample, the rectangular-shaped window 954 has a width “W” that isapproximately one-fourth of the circumference of the hollow outer sheath950 and a length of approximately 0.25 inches. The sheath 950 may befabricated from, for example, stainless steel.

This embodiment also employs a blade 960 that can be used in connectionwith any of the surgical instrument embodiments described above orothers. For example, a waveguide or proximal portion of the blade may beconfigured for attachment to the instrument's ultrasonic horn or motordrive shaft by a threaded or other connection. As can be seen in FIGS.52-54, the blade 960 has a pair of radially-opposed sharpened cuttingedges 962 formed thereon that serve to cut tissue “T” that is drawn intothe window 954 of the outer sheath 950. In various embodiments, theblade 960 may be fabricated from, for example, Titanium and be sizedrelative to the outer sheath 950 such that a clearance “C” is providedbetween the inner wall 951 of the outer sheath 950 and the tips of theradially opposed sharpened cutting edges 962. See FIG. 54. In someembodiments, for example, the clearance “C” may be approximately 0.001inches. In this embodiment, the blade 960 may be fabricated from, forexample, Titanium and have a flattened distal end 964. In use, whengross rotary motion is applied to the blade 960 in any of the variousmanners described above and suction is applied within the hollow outersheath 950, the tissue “T” is drawn in through the window 954 andtrapped between the blade 960 and the inner wall 951 of the outer sheath950. This action isolates the tissue “T” long enough to cut when, forexample, the device is employed in an aqueous environment as will bediscussed in further detail below. In some embodiments, the cuttingedges 962 may be serrated. In other embodiments the cutting edges 962are not serrated.

FIG. 57 depicts another non-limiting blade and sheath embodiment. Thisembodiment employs a hollow outer sheath 970 that may be attached to thenosepiece or ultrasonic transducer assembly of any of the variousinstruments described above. As can be seen in FIG. 56, the outer sheath970 has a rounded or blunted nose portion 972 and an elongated window oropening 974 that forms a blade access hole 976 in the nose portion 972and two radially-opposed lateral window portions 978. In one embodiment,for example, wherein the outer diameter of the outer sheath 970 isapproximately 0.157 inches, the diameter of the blade access hole 976may be approximately 0.125 inches. The lateral window portions 978 mayeach have a width “W” of approximately 0.090 inches and a length “L” ofapproximately 0.25 inches. Other window sizes/configurations may beemployed. The sheath 970 may be fabricated from, for example, stainlesssteel.

This embodiment also employs a blade 980 that has a waveguide orproximal portion that is configured for attachment to the ultrasonichorn or motor drive shaft of any of the various surgical instrumentembodiments described above 324 by a threaded or other suitableconnection. In various embodiments, the blade 980 may be substantiallythe same as blade 960 described above (with radially-opposed sharpenedcutting edges 982), except that blade 980 has a rounded/substantiallyblunted distal tip portion 984 that protrudes out through the bladeaccess hole 976 in the outer sheath 970. See FIG. 57. In variousembodiments, the blade 980 may be fabricated from, for example, Titaniumand be sized relative to the outer sheath 970 such that a clearance isprovided between the inner wall 971 of the outer sheath 970 and the tipsof the radially opposed sharpened cutting edges 962. In someembodiments, for example, the clearance may be approximately 0.001inches. In use, when gross rotary motion is applied to the blade 980 inany of the various manners described above and suction is applied withinthe hollow outer sheath 970, the tissue is drawn in through the windowportions 978 and trapped between the blade 980 and the inner wall 971 ofthe outer sheath 970. This action isolates the tissue long enough to cutwhen, for example, the device is employed in an aqueous environment aswill be discussed in further detail below. Also, in this embodiment,when the blade 980 is ultrasonically powered, the clinician can use theexposed distal tip portion 984 for spot ablation of fibrous tissue orfor spot coagulation purposes. In some embodiments, the cutting edges982 may be serrated. In other embodiments the cutting edges 982 are notserrated.

FIG. 59 depicts another non-limiting blade and sheath embodiment. Thisembodiment employs a hollow outer sheath 990 that may be attached to thenosepiece or ultrasonic transducer assembly of any of theabove-described surgical instruments by any suitable fastening method orconnection arrangement. As can be seen in FIG. 58, the outer sheath 990has a closed rounded or blunted nose portion 992 and an elongatedrectangular-shaped window or opening 994. In one embodiment, forexample, the rectangular-shaped window 994 has a width “W” that isapproximately 0.100 inches and a length of approximately 0.25 inches.The sheath 990 may be fabricated from, for example, a polyamide orsimilar material that does not result in the heating of a blade 1000from contact therewith. The window 994 may be defined by sharp edges995, 997. As can be seen in FIG. 60, edges 995, 997 may be provided withan angle “B” therebetween. In some embodiments, angle “B” may beapproximately 110 degrees.

These embodiments also employ a blade 1000 that has a waveguide orproximal portion that is configured for attachment to the ultrasonichorn or motor drive shaft of any of the above-described surgicalinstruments or others by a threaded or other suitable connectionarrangement. As can be seen in FIG. 59, the blade 1000 may have a pairof radially-opposed sharpened cutting portions 1002 formed thereon thatserve to cut tissue that is drawn into the window 994 in the outersheath 990. In various embodiments, the blade 1000 may be fabricatedfrom, for example, Titanium. The cutting portions 1002 of the blade 1000may have sharp cutting corners 1003 formed thereon. In some embodiments,the cutting corners 1003 may be serrated. In other embodiments thecutting corners 1003 are not serrated. The cutting portions 1002 may besized relative to the outer sheath 990 to establish a tissue shearingaction between the cutting corners 1003 and the sharp edges 995, 996 ofthe window opening 994 as the blade 1000 is rotated or oscillated backand forth within the outer sheath 990. The blade 1000 may be sizedrelative to the outer sheath 990 to create a slip fit therebetween thatotherwise prevents tissue from becoming trapped between those twocomponents. The blade 990 could rotate back and forth (arrow “D”) orrotate in a single direction (arrow “E”) and if desire be ultrasonicallyactivated as well as was discussed above. See FIG. 59. In use, whengross rotary motion is applied to the blade 1000 in any of the variousmanners described above and suction is applied within the hollow outersheath 990, the tissue “T” is drawn in through the window 994 andtrapped between the blade 1000 and the inner wall 999 of the outersheath 990. This action isolates the tissue long enough to cut when, forexample, the device is employed in an aqueous environment as will bediscussed in further detail below.

FIG. 62 depicts another non-limiting blade and sheath embodiment. Thisembodiment employs a hollow outer sheath 1010 that may be attached tothe nosepiece or ultrasonic transducer assembly of any of the abovedescribed surgical instruments by any suitable fastening method orconnection arrangement. As can be seen in FIG. 61, the outer sheath 1010may have a closed rounded or blunted nose portion 1012 and an elongatedrectangular-shaped window or opening 1014. In one embodiment, forexample, the window 1014 has a first coined or depressed edge 1016 and asecond coined or depressed edge 1018 to define an opening 1019 that mayhave a width W″ that is approximately 0.100 inches. Window 1014 may havea length of approximately 0.25 inches. The sheath 1010 may be fabricatedfrom, for example, stainless steel

These embodiments also employ a blade 1020 that has a waveguide orproximal portion that is configured for attachment to the ultrasonichorn or motor drive shaft of any of the above-described surgicalinstruments or others by a threaded or other suitable connection. As canbe seen in FIG. 62, the blade 1020 may have a pair of radially-opposedsharpened cutting portions 1022, 1024 formed thereon. The blade 1020 maybe fabricated from, for example, Titanium and have relative sharpcutting corners 1025 formed on each cutting portions 1022, 1024. In someembodiments, the cutting corners 1025 may be serrated. In otherembodiments the cutting corners 1025 are not serrated. The cuttingportions 1022, 1024 may be sized relative to the outer sheath 1010 toestablish a tissue shearing action between the depressed edges 1016,1018 and the cutting corners 1025 as the blade 1020 is rotated oroscillated within the outer sheath 1010. Such arrangement forms arelatively small localized area to lessen contact issues between theblade and the outer sheath by also facilitates a scissoring effect onthe tissue. In use, when gross rotary motion is applied to the blade1020 in any of the various manners described above and suction isapplied within the hollow outer sheath 1010, the tissue is drawn inthrough the opening 1019 and trapped between the blade 1020 and theinner wall 1011 of the outer sheath 1010. This action isolates thetissue long enough to cut when, for example, the device is employed inan aqueous environment as will be discussed in further detail below.

FIG. 64 depicts another non-limiting blade and sheath embodiment. Thisembodiment employs a hollow outer sheath 1030 that may be attached tothe nosepiece or ultrasonic transducer assembly of any of theabove-described surgical instruments. As can be seen in FIG. 63, theouter sheath 1030 may have a closed rounded or blunted nose portion 1032and an elongated rectangular-shaped window or opening 1034. Thisembodiment may further include a pair of sharpened cutting inserts 1036,1038. The cutting inserts 1036, 1038 may be fabricated from, forexample, hardened stainless steel and be attached within the hollowsheath 1030 by, for example, welding. Window 1034 may have a width W″that is approximately 0.100 inches and a length of approximately 0.25inches. The sheath 1030 may be fabricated from, for example, stainlesssteel.

These embodiments also employ a blade 1040 that has a waveguide orproximal portion that is configured for attachment to the ultrasonichorn or motor drive shaft of any of the surgical instruments describedherein or others by a threaded or other suitable connection. As can beseen in FIG. 64, the blade 1040 has a pair of radially-opposed cuttingportions 1042 formed thereon that have relatively sharp cutting corners1043. In some embodiments, the cutting corners 1043 may be serrated. Inother embodiments the cutting corners 1043 are not serrated. In variousembodiments, the blade 1040 may be fabricated from, for example,Titanium and be sized relative to the cutting inserts 1036, 1038 toestablish a tissue shearing action between the sharp cutting corners1043 and the cutting portions 1042 as the blade 1020 is rotated oroscillated within the hollow outer sheath 1030. The outer diameter ofthe blade 1020 is smaller than the inner diameter of the outer sheath1030 to provide clearance for the blade 1040 during operation. The onlyinstance of contact would be between the cutting portions 1042 of theblade 1040 and the inserts 1036, 1038 along the window opening 1034wherein the tissue is pulled in by the suction.

FIG. 66 depicts another non-limiting blade and sheath embodiment. Thisembodiment employs a hollow outer sheath 1110 that may be attached tothe nosepiece or ultrasonic transducer assembly of any of the surgicalinstruments described above by any suitable fastening method orconnection arrangement. As can be seen in FIG. 65, the outer sheath 1110may have a closed rounded or blunted nose portion 1112 and an elongatedrectangular-shaped window or opening 1114. In this embodiment, thelateral edge portions 1116, 1118 of the window 1114 are coined ordepressed inward. Window 1014 may have a width W″ that is approximately0.10 inches and a length of approximately 0.25 inches.

These embodiments also employ a blade 1120 that has a waveguide orproximal portion that is configured for attachment to the ultrasonichorn or motor drive shaft of any of the surgical instrument embodimentsdescribed above or others by a threaded or other suitable connectionarrangement. As can be seen in FIG. 66, the blade 1120 has a pair ofradially-opposed cutting portions 1122 formed thereon that haverelatively sharp cutting corners 1023. In some embodiments, the cuttingcorners 1023 may be serrated. In other embodiments the cutting corners1023 are not serrated. In various embodiments, the blade 1020 may befabricated from, for example, Titanium and be sized relative to thedepressed edges 1116, 1118 to establish a tissue shearing action betweenthe sharp cutting corners 1023 and the cutting portions 1122 as theblade 1120 is rotated or oscillated. Such arrangement defines a largerclearance C1 between the cutting portions 1122 of the blade 1120 and theinner wall 1111 of the sheath 1110. To form a tissue shearing actionbetween the lateral edges 1116, 1118 and the cutting portions 1122, aclearance C2 that is less than C1 is provided.

FIGS. 67-69 depict another non-limiting blade and sheath embodiment.This embodiment employs a hollow outer sheath 1210 that may be attachedto the nosepiece or ultrasonic transducer assembly of any of thesurgical instruments described above. The hollow outer sheath 1210 has adistal nose portion 1212 that includes an upper opening 1214 and a loweropening 1215 that serve to define arcuate lateral side portions 1216,1218. The distal nose portion 1212 may further have a closed end 1219that extends between the lateral side portions 1216, 1218.

This embodiment further comprises a blade 1220 that has a waveguide orproximal portion that is configured for attachment to the ultrasonictransducer assembly of any of the surgical instruments described above.The blade 1220 further has a distal end portion 1221 that has a cavity1222 that serves to define a pair of arcuate cutting portions 1224, 1226that extend above the arcuate lateral side portions 1216, 1218 of thehollow sheath 1210. One, both or neither of the cutting portions 1224,1226 may have serrated teeth 1227. In the embodiment depicted in FIG.67, the cavity 1222 has a cross-sectional shape that roughly resembles aflat bottom “C”. However, the cavity 1222 may have other cross-sectionalshapes. At least one suction passage 1230 may be provided through theblade 1220 as shown. The suction passage may communicate with a sourceof suction (not shown).

In various embodiments, the blade 1220 may be fabricated from, forexample, Titanium and be sized relative to the distal nose portion 1212of the hollow sheath 1210 such that the bottom portion 1232 of the blade1220 extends downward beyond the lateral sides 1216, 1218 of the noseportion 1212. Likewise, the cutting edges of the arcuate side portions1224, 1226 extend above the lateral sides 1216, 1218 as shown in FIG.67. The exposed bottom portion 1232 of the blade 1220 may be used, forexample, to coagulate tissue, while the cutting edges 1224, 1226 may beused to cut and sever tissue.

The proximal end 1211 of the hollow sheath 1210 protrudes from a handlehousing 1240 as shown in FIG. 70. The handle housing 1240 houses anultrasonic transducer assembly, a motor, and a slip ring assembly as wasdescribed above and is coupled to a control system 10. The handlehousing 1240 may include a selector switch 1241 which enables theclinician to switch between a first “ultrasonic” mode 1242, a second“shaver” mode 1244, and a third “injection” mode 1246. The switchingmechanism 1241 communicates with the control system 10 to automaticallyorient the blade 1220 in a desired rotational orientation. For example,to employ the device 1200 in the ultrasonic mode 1242, the clinicianswitches the selector switch 1241 to the ultrasonic mode position 1242(depicted as action 1250 in FIG. 71). When in the first ultrasonicconfiguration 1242, the motor will rotate the blade 1220 to the positionshown in FIGS. 67 and 68 (depicted as action 1252 in FIG. 71) and thenpark it in that position to expose the bottom portion 1232 of the blade1220 through the hollow sheath 1210 (depicted as action 1254 in FIG.71). When in that position, the ultrasonic transducer assembly isactivated to enable the bottom portion 1232 to be used to achievehemostasis (depicted as action 1257 in FIG. 71). More particularly, whenin the ultrasonic mode 1242, the clinician may orient the bottom portion1232 against the tissue that is bleeding and then apply firm pressure tothe tissue (depicted as action 1256 in FIG. 71) with the exposed portion1232 of the blade 1220. The clinician then activates the ultrasonictransducer assembly to achieve hemostasis (depicted as action 1258 inFIG. 71). In alternative embodiments, the device 1200 may be providedwith a series of switches/buttons as was described above thatcommunicate with a control system such that activation of one switch mayinitiate rotation. Activation of another switch may initiate rotatableoscillation and activation of another switch may, in cooperation withthe control system rotate the blade to the ultrasonic position and parkit and thereafter activate the ultrasonic transducer assembly or instill other embodiments, the ultrasonic transducer assembly may beactivated by yet another separate switch. All of such alternativearrangements are within the scope of the various non-limitingembodiments disclosed herein and their respective equivalent structures.

FIG. 72 illustrates use of the device 1200 when in the shaver mode 1244.In particular, the selector switch 1241 is moved to the shaver position1242 (depicted as action 1260 in FIG. 72). When in that position, themotor continuously rotates the blade 1220 within the hollow outer sheath1210 (depicted as action 1262 in FIG. 72). In other embodiments, themotor may rotatably oscillate the blade 1220 back and forth within theouter sheath 1210 or in other embodiments, the selector switch may bemovable to yet another position wherein the rotatable oscillation isinitiated. In either case, the clinician may then contact tissue withthe rotating or oscillating blade (1220) to cause the tissue to beshaved and evacuated through the suction passage 1230 (depicted asaction 1264 in FIG. 72).

FIG. 73 illustrates use of the device 1200 when in the injection mode1246. In particular, the selector switch 1241 is moved to the injectionposition 1246 (depicted as action 1270 in FIG. 73). When in thatposition, the blade 1220 is retained in a parked position (depicted asaction 1272 in FIG. 73). The clinician may then orient the blade in adesired position and then inject the desired medicament (depicted asaction 1274 in FIG. 73). One form of medicament that may be injected forexample may comprise a cell generating drug sold under the trademark“Carticel”. However, other drugs and medicaments could be employed. Theinjection action may be accomplished by orienting the blade 1220 to aposition within the outer sheath 1210 such that a medicament passage1284 extending through the blade 1220 is exposed through the outersheath 1210 to enable medicament to be advantageously applied to theadjacent site. The medicament may then be injected by activating a pump1280 that communicates with a source of the medicament 1282. See FIG.70. In various embodiments, the device 1200 may have an injectiontrigger 1249 that communicates with the pump 1280 such that activationof the injection trigger 1249 will cause the pump 1280 to inject themedicament out through the passage 1284 (FIG. 68). In alternativeembodiments, the medicament may be manually injected by, for example, asyringe into a port (not shown) that communicates with medicamentpassage 1284 in blade 1220.

FIGS. 74-77 depict another non-limiting surgical instrument embodiment1300. The device 1300 may include any one of the handpiece devices 300,400, 500 described above. For example, the device 1300 may include ahandpiece 300 that incorporates the difference noted below. Thehandpiece 300 includes a blade 200 that has a waveguide or proximalportion that is coupled to an ultrasonic transducer assembly that, whenactivated, applies ultrasonic motion to the blade 200. The blade 200 mayalso be rotated by the motor arrangement contained within the handpiece300 as described above. The blade 200 may extend through an inner sheath1320 that protrudes from the handpiece 300. The blade 200 is free to beselectively vibrated and rotated within the inner sheath 1320. One ormore seal members 1322 may be provided between the blade 200 and theinner sheath 1320 to prevent fluids and tissue from entering the areabetween the inner sheath 1320 and the blade 200. The seal members 1322may be fabricated from, for example, silastic silicone.

The device 1300 may further include an outer sheath 1330 that is movablyreceived on the inner sheath 1320. The outer sheath 1330 may be sizedrelative to the inner sheath 1320 such that a suction tube 1350 mayextend between a portion of the inner sheath 1320 and a portion of theouter sheath 1330. The suction tube 1350 may communicate with a sourceof suction generally depicted as 1352. See FIG. 74. As can be seen inFIGS. 74-77, the outer sheath 1330 may include a swing arm portion 1332that protrudes distally from a distal end portion 1331 of the outersheath 1330. The swing arm 1332 may be relatively straight (FIG. 75) orit may have a slightly curved distal end 1334 (FIG. 76). As can be seenin FIG. 76, the distal end 1334 may have a sharpened cutting surface1336 thereon. As can also be seen in FIGS. 74-76, in some embodiments,the blade 200 may have a curved blade tip 1360 that has a pair oflateral cutting edges 1362 formed thereon. In other embodiments, theblade tip 1360 may be straight. In some embodiments, the blade 200 maybe rotated in the various manners discussed above. In other embodiments,the blade 200 may not rotate. In such embodiments, for example, theclinician may choose not to activate the motor for rotating the blade orthe handpiece may comprise a handpiece that does not include a motor forrotating the blade.

In use, the swing arm portion 1332 may cover portions of the distal end1360 of the blade 200. In one mode of use, the outer sheath 1330 isretained in position wherein the swing arm portion 1332 covers the backside of the blade 200 as shown in FIG. 74. Such arrangement leaves thecurved blade tip 1360 exposed. When in such position, for example, thecurved blade tip 1360 could be employed to transect tissue, such as themeniscus. In a second mode of operation, the swing arm portion 1332 ismoving.

In the embodiment depicted in FIGS. 74-77, a suction tube 1350 isemployed to draw loose tissue towards the blade tip 1360 and also removesmall sections of transected tissue during cutting. In otherembodiments, suction could occur in the annular space between thesheaths 1320, 1330. In still other embodiments, the blade 200 may have asuction path (not shown) extending therethrough which ultimatelycommunicates with a source of suction as was described above. Suchsuction path would most likely exit the blade 200 at the node at theproximal end. In still other embodiments, no suction is employed.

In some embodiments, the swing arm portion 1332 may be permanentlyretained in position against the blade 200. In still other embodiments,a lubricious or low friction pad (not shown) may be mounted to the swingarm portion 1332 such that the pad contacts the blade 200. In otherembodiments, a 0.002″-0.010″ clearance may be provided between the swingarm portion 1332 and the blade 200. In other embodiments, the swing armportion 1332 extends around the length of the curved portion of theblade 200 so that the entire blade 200 is covered from the back side.

The various non-limiting embodiments described hereinabove may beeffectively employed in a connection with a variety of differentsurgical applications and are particularly well-suited for cutting andcoagulating tissue in the aqueous environment of arthroscopic surgery.In such applications, however, if fluid passes between the blade orwaveguide and the inner sheath, the fluid may enter the housing anddamage the components therein. Various sealing arrangements are knownfor use with ultrasonically powered surgical instruments. For example,U.S. Pat. No. 5,935,144 and U.S. Pat. No. 5,944,737, the disclosures ofwhich are each herein incorporated by reference in their respectiveentireties, each disclose various sealing arrangement for use withultrasonic surgical instruments in the traditional environment oflaparoscopic surgery and open surgery (i.e., non-aqueous environments).However, various non-limiting embodiments discussed below employimproved sealing arrangements that may be better suited for use inaqueous environments.

More particularly and with reference to FIG. 78, there is shown anultrasonic device 1400 that includes a housing 1402 that rotatablysupports an ultrasonic transducer assembly 1404 therein. For example,the ultrasonic transducer assembly 1404 may be rotatably supportedwithin the housing 1402 by a series of bearings (not shown). Anultrasonic horn 1406 may be coupled to the ultrasonic transducerassembly 1404 and an ultrasonic implement 1410 is attached thereto byconventional means which may typically comprise a threaded arrangement.As used herein, the term “ultrasonic implement” may encompass any one ofthe blade and cutting member embodiments described herein. The portionof the ultrasonic implement 1410 that is coupled to the ultrasonic horn1406 may be referred to as a waveguide portion 1412. The waveguide 1412may comprise an integral portion of the ultrasonic implement 1410 or itmay comprise a separate component attached thereto by, for example, athreaded connection. In the embodiment depicted in FIG. 78, theultrasonic implement 1410 extends through a hollow outer sheath 1420.The outer sheath 1420 and the distal end of the ultrasonic implement1410 may be configured in any one of the various blade and sheathconfigurations described hereinabove as well as others.

As can also be seen in FIG. 78, a proximal shaft 1430 is attached to theultrasonic transducer assembly 1404. Attached to the proximal shaft 1430is a driven gear 1432 that is in meshing engagement with a drive gear1434 coupled to an out put shaft 1436 of a motor 1440. Ultrasonicelectrical signals and the motor control signals may be supplied fromthe control system 10 through a slip ring assembly 1450 of the type andconstruction described above. The device 1400 may further comprise thevarious control button arrangements described above, so that the devicemay be used in a ultrasonic mode, a non-ultrasonic mode (e.g.,rotational shaving mode) and a combination of such modes. Unlike thevarious instruments described above, the motor 1440 is not coaxiallyaligned with the ultrasonic transducer assembly.

FIG. 79 depicts a non-limiting embodiment of a seal assembly 1470 thatmay be employed between in the waveguide or proximal portion 1412 of theultrasonic implement 1410 and the outer sheath 1420. The seal 1470comprises an annular member that may be fabricated from silicon or othermaterials such as, for example, Ultem® and is over molded or otherwisesealingly attached to the waveguide 1412 at a node “N”. The seal 1470may have a first annular seal portion 1472 that is molded onto thewaveguide 1412 at a node “N” and two axial seal portions 1474, 1476 thatextend axially in opposite axial directions beyond the first annularseal portion 1472 and which are separated by a groove 1478. The groove1478 may enable the two axial seal portions 1474, 1476 to somewhat flexrelative to each other in sealing contact with the outer sheath 1420.The narrower first annular seal portion 1472 may avoid excessive heatbuild-up while providing a wider contact area wherein the seal 1470contacts the outer sheath 1420.

FIG. 80 depicts anon-limiting embodiment of a seal 1480 that may beemployed between in the waveguide or proximal portion 1412 of theultrasonic implement 1410 and the outer sheath 1420. The seal 1480comprises an annular member that may be fabricated from silicon or othermaterials, such as for example, Ultem® and is over molded or otherwisesealingly attached to the waveguide 1412 at a Node “N”. The seal 1480may be arranged to abut an inwardly-extending annular abutment ring 1490formed on the outer sheath 1420. The seal 1480 is located distal withrespect to the abutment ring 1490. When the fluid pressure builds upwithin the distal end of the outer sheath 1420, the seal 1480 is forcedinto the abutment ring 1490 thereby increasing the strength of the seal.The outer sheath 1420 may be fabricated from, for example, stainlesssteel.

FIG. 81 depicts a non-limiting embodiment of a seal 1500 that may beemployed between in the waveguide portion 1412 of the blade 1410 and theouter sheath 1420. The seal 1500 comprises an annular member that may befabricated from silicon or other materials, such as for example, Ultem®and is over molded or otherwise sealingly attached to the waveguide 1412at a Node “N”. The seal 1480 may be arranged to be received within anannular groove 1423 provided in the outer sheath 1420. The outer sheath1420 may be fabricated from, for example, stainless steel.

FIG. 82 depicts a non-limiting embodiment of a seal 1510 that may beemployed between in the waveguide or proximal portion 1412 of theultrasonic implement 1410 and the outer sheath 1420. The seal 1510comprises an annular member that may be fabricated from silicon or othermaterials such as, for example, Ultem® and is over molded or otherwisesealingly attached to the waveguide 1412 at a node “N”. The seal 1510may have an inner rim portion 1512 that is molded onto the waveguide1412 at a node “N” and two axial seal portions 1514, 1516 that extendaxially in opposite directions beyond the inner portion 1512 and whichare separated by a groove 1518. The axial portions 1514, 1516 are sizedto extend into a groove 1520 provided in the outer sheath 1420. As canbe seen in FIG. 82, the groove 1520 has an inwardly protruding ring 1522sized to extend into the groove 1518 in the seal 1510. In theillustrated embodiment, the ring 1522 has an angled ramp 1524 formedthereon that permits the seal 1510 to slide over it during assembly,then lock in place. The outer sheath 1420 may be fabricated from, forexample, Ultem®.

FIGS. 83 and 84 depict a non-limiting embodiment of a seal 1530 that maybe employed between in the waveguide or proximal portion 1412 of theultrasonic implement 1410 and the outer sheath 1420. The seal 1530comprises an annular member that may be fabricated from silicon or othermaterials such as, for example, Ultem® and is over molded or otherwisesealingly attached to the waveguide 1412 at a node “N”. The seal 1530may have a groove 1532 therein as shown in FIG. 83. The outer sheath1420 is then crimped to thereby crush the seal 1530 as shown in FIG. 84.The outer sheath 1420 could be crimped evenly all the way around thecircumference, or it could be crimpled in discrete locations. Forexample, four evenly spaced (e.g., at 90 degree intervals) crimps may beemployed. In such embodiments, the outer sheath 1420 may be fabricatedfrom, for example, stainless steel.

FIG. 85 depicts a portion of an outer sheath 1540 that has a proximalaxial portion 1542 and a distal axial section 1544 that are adapted tobe interconnected together by, for example, welding, press fit,threading or snapping together. As can be seen in FIG. 85, the distalaxial section 1544 has a groove portion 1546 sized to engage a portionof an annular seal 1550 that is over molded or otherwise sealinglyinstalled on the waveguide or proximal portion 1412 of the ultrasonicimplement 1410 at a node “N”. Thus, when attached together, the proximalaxial section 1542 and distal axial section 1544 serve to trap andcompress a portion of the seal 1550 therebetween. In alternativeembodiments, the groove portion 1546 may be provided in the proximalaxial section 1542 or each section 1542, 1544 may have a groove segmenttherein that cooperate to accommodate the annular seal 1550 therein.

FIG. 86 depicts a portion of an outer sheath, generally designated as1560 that consists of two lateral halves 1562, 1564. Each lateral half1562, 1564 has a semi-annular groove segment 1566 formed therein. SeeFIG. 87. The semi-annular groove segments 1566 form an annular groove1568 sized to receive an annular seal 1570 that is over molded onto orotherwise attached to the waveguide or proximal portion 1412 when thelateral halves 1562, 1564 are joined together to form the hollow outersheath 1560. By creating a two piece outer sheath 1560, the seal 1570could have much greater interference with the outer sheath 1560, than itgenerally could have if the waveguide 1412 must be pushed down the outersheath 1560 during the assembly process. The two outer sheath halves1562, 1564 may be joined together by welding, snap fitting or othersuitable methods. Thus, the seal 1570 may first be installed on thewaveguide 1412. Thereafter, the two halves 1562, 1564 may be broughttogether around the wave guide 1412 such that the seal 1570 is trappedwithin the groove 1568. The halves 1562, 1564 are then fastened togetherin that position.

FIG. 88 depicts a non-limiting embodiment of a seal 1580 that may beemployed between in the waveguide portion 1412 of the ultrasonicimplement and the outer sheath 1420. The seal 1580 comprises an annularmember that may be fabricated from silicon or other materials such as,for example, Ultem® and is over molded or otherwise sealingly attachedto the waveguide or proximal portion 1412 at a node “N”. The seal 1580may be held in place by a proximal ring 1590 and a distal ring 1592. Theproximal ring 1590 may comprise an integral portion of the outer sheath1420 or it could comprise a separate component that is pressed into theouter sheath 1420 or otherwise attached thereto. The distal ring 1592may be glued, press fit or otherwise attached to the outer sheath 1420.The distal ring 1592, upon installation, may provide compression on theseal 1580. This would increase the force between the seal 1580 and thewaveguide 1412, further decreasing fluid movement past the seal 1580.The rings 1590, 1592 may comprise split annular rings or rings with nosplits therein. In addition, as can be seen in FIG. 88 the tings 1590,1592 may be sized relative to the waveguide 1412 such that an amount ofclearance “C” is provided therebetween.

FIG. 89 depicts a non-limiting embodiment of a seal 1600 that may beemployed between in the waveguide or proximal portion 1412 of anultrasonic implement 1410 and the outer sheath 1420. The seal 1600comprises an annular member that may be fabricated from silicon or othermaterials such as, for example, Ultem® and is over molded or otherwisesealingly attached to the waveguide 1412 at a node “N”. The seal 1600may have an outer diameter that is greater than the inner diameter ofthe outer sheath 1420. The seal 1600 may further have a proximal side1602 and a distal side 1604. When assembled, an outer portion of theproximal side 1602 of the seal 1600 sealingly contacts the inner wall1421 of the outer sheath 1420. Thus, when fluid pressure “P” builds upon the distal side of the seal 1600, the seal 1600 is further urged intosealing contact with the outer sheath 1420, thereby creating a betterseal between the waveguide 1412 and the outer sheath 1420.

FIG. 90 depicts a non-limiting embodiment of a seal 1610 that may beemployed between in the waveguide or proximal portion 1412 of the bladeand the outer sheath 1420. The seal 1610 comprises an annular memberthat may be fabricated from silicon or other materials such as, forexample, Ultem® and is molded or otherwise attached to the outer sheath1420 as shown. In this embodiment, an annular groove 1620 may beprovided in the waveguide 1412 for receiving a portion of the seal 1610therein. In alternative embodiments, no groove is provided. It will befurther understood that the seals depicted in FIGS. 79-82 may likewisebe attached to the outer sheath instead of the waveguide or proximalportion of the cutting blade or implement as illustrated withoutdeparting from the spirit and scope of the various non-limitingembodiments disclosed herein and their respective equivalents. Inaddition, it will be further understood that the various sealembodiments described herein may be effectively employed with any of thesurgical instrument embodiments described above. That is, the variousnon-limiting seal arrangements disclosed herein and their respectiveequivalent structures may be effectively employed to achieve a sealbetween the ultrasonic blade or waveguide and the corresponding innersheath. In those embodiments that employ an inner sheath and an outersheath, but do not apply a suction therebetween, the variousnon-limiting seal arrangements disclosed herein and their respectiveequivalents may also be effectively employed to achieve a substantiallyfluid-tight seal between the inner and outer sheaths. In yet othernon-limiting embodiments, the seal may be employed between an ultrasonicblade and an outer sheath wherein the ultrasonic blade does not engagein gross-rotational motion relative to the outer sheath. In suchembodiments, the seal may be rigidly attached to the ultrasonic bladeand the outer sheath. In still other non-limiting embodiments, theultrasonic blade may oscillate within the outer sheath. For example theultrasonic blade may oscillate through a 90 degree arc (45 degrees oneach side of a central axis). In such embodiments, the seal may berigidly attached to the outer sheath and ultrasonic blade by, forexample, adhesive, crimping, etc. The seal material may comprise anelastic rubber material or the like that would accommodate twisting ofthe seal for a range of ±45 degrees. In such embodiments, the stretchexperienced by the seal may help to return the blade to a neutralposition of zero degrees (in alignment with the central axis).

Various of the above-described embodiments employ rotating blades thatserve to shear off tissue between cutting edges formed on the blade andedges of the surrounding outer sheath. While such arrangements are veryeffective in cutting most tissues, tough tissue, such as tendon tissuefor example, can be difficult to effectively cut because it can tend to“milk” between the blade and the outer sheath. Such problem is akin toproblems encountered when scissors are used to cut through a toughmaterial such as leather, for example. In short, the scissor bladesseparate and the material does not get cut. This phenomenon isgraphically depicted in FIGS. 91A-D. As can be seen in those Figures,two cutting blades 1700 are employed to cut through tough tissue “T”. Asthe blades 1700 move inward toward the tissue “T”, the tissue “T” movesbetween the blades 1700 and causes them to separate.

In various blade and sheath embodiments disclosed herein, it may beadvantageous to minimize the amount of clearance between the cuttingportion of the outer sheath and the cutting edge(s) of the blades. Forexample, it may be desirable to maintain the amount of clearance betweenthe cutting portion of the outer sheath and the cutting edge(s) on theblades within the range of 0.001″ to 0.005″. In other non-limitingembodiments, one cutting edge or portion is harder than the othercutting portion. For example, the cutting edge(s) on the blades may beharder than the cutting portion of the outer sheath or visa versa. Themotor may then be activated with or without ultrasound to achieve a nearzero clearance between the cutting edges/portion. In addition to suchapproaches or in place of such approaches, other embodiments may employstructure to bias at least a distal portion the blade in an “off-center”arrangement within the outer sheath while still facilitating therotation of the blade therein. More particularly and with reference toFIGS. 92-93, there is shown a blade 200 of the type and constructiondescribed above, extending through an outer sheath assembly 3000. In thedepicted embodiment, the outer sheath assembly 3000 is used inconnection with a surgical instrument 3001 that may be constructed inany of the manners described above to selectively apply gross rotationalmotion to the blade 200 as well as to selectively apply ultrasonicmotion thereto.

In the embodiment depicted in FIG. 93, the blade 200 extends axiallythrough an inner sheath 3020 that is mounted within a portion of theinstrument housing 3010. The outer sheath assembly 3000 is attached tothe instrument housing 3010 and has a distal tip portion 3002 that has awindow or opening 3004 therein. As discussed above, the window 3004enables tissue to be drawn into a tip cavity 3006 formed within thedistal tip portion 3002. Suction may be applied to the tip cavity 3006through a suction port 3007 in the distal tip portion 3002 of the outersheath assembly 3000 that communicates with a source of suction 244. Inthese embodiments, the blade 200 is somewhat flexible and may befabricated from, for example, Titanium. In addition, the waveguideportion or proximal portion of blade 200 extends through a bushing 3030that is mounted within the inner sheath 3020 in the location of node“N”. In various embodiments, the inner sheath 3020 may be fabricatedfrom material that is substantially rigid and resists bending. Forexample, the inner sheath 3020 may be fabricated from Ultem or similarmaterials. The bushing 3030 may be fabricated from, for example Ultem®and be non-rotatably retained within the inner sheath 3020 by, forexample, stainless steel.

As can be seen in FIGS. 92A and 93, the waveguide or proximal portion701 of blade 200 extends through a hole 3032 in the bushing 3030. Thecenterline CL-CL of the bushing hole 3032 is offset (i.e., not coaxialwith) from the central axis A-A defined by the outer sheath 3000. Thebushing hole 3032 is sized relative to the proximal portion 701 of theblade 200 to permit the proximal portion 701 to rotate freely therein,yet also serves to bias the distal end portion 700 of the blade 200 offthe center axis A-A of the outer sheath 3000 such that the tissuecutting distal end 705 of the blade 200 is retained in rotatable contactwith the cutting edge 3005 defined by the window opening 3004. In someembodiments, for example, the blade 200 may be biased off center adistance that can be as much as 0.030″. Because the tissue cuttingdistal end 705 of the blade 200 is biased in such a manner, the distalend 705 resists forces encountered when cutting tough tissue which mayotherwise cause cutting edges 706 on the distal end 705 to move awayfrom the cutting edge 3005 of the window opening 3004.

FIGS. 94 and 95 illustrate another embodiment wherein a proximal portion701 of the blade 200 coaxially extends through a bushing 3040 that maybe fabricated from, for example, silastic silicone or Ultem® and beretained within the inner sheath 3020 by, for example, a slip fit. Aswith the above embodiment, the bushing 3040 may be located at the node“N” along the waveguide or proximal portion of the blade 200. However,in this embodiment, the distal portion 711 (i.e., the portion of theblade 200 that extends distally from the bushing 3040) is bent slightlyto bias the tissue cutting distal end 705 of the blade 200 into thecutting edge 3005 of the window opening 3004. For example, the distalportion 711 of the blade 200 may be bent approximately 0.030 inchesoff-center (distance OS in FIG. 95). Such arrangement causes the tissuecutting distal end 705 of the blade 200 to resist forces when cuttingtough tissue which may otherwise cause cutting edges 706 on the blade200 to move away from the cutting edge 3005 of the window opening 3004.

FIGS. 96-97 depict another non-limiting outer sheath 3040 and blade 200embodiment. In this embodiment, a distal outer sheath tip 3050 isemployed. The distal outer sheath tip 3050 may be fabricated from metalsuch as, for example, stainless steel and have a proximal bearingportion 3052 that extends into an open distal end 3062 of the outersheath 3060. The outer sheath 3060 may be fabricated from, for example,stainless steel and may be attached to the distal outer sheath tip 3050by fasteners, adhesive, etc. The proximal end 3062 of the outer sheath3060 is attached to a portion of an instrument housing as was describedabove. The instrument may comprise many of the various instrumentembodiments described in detail above that supplies gross rotationalmotion to the blade 200 as well as ultrasonic motions thereto.

The waveguide or proximal portion 701 of the blade 200 may be attachedto an ultrasonic horn (not shown) and extend through an inner sheath3070 in the various manners described above. The proximal portion 701 ofthe blade 200 may be rotatably supported within the inner sheath 3070 bya bushing 3040 as was described above. A distal portion 711 of the blade200 rotatably extends through a lumen 3054 in the distal outer sheathtip 3050. See FIG. 97. A window 3056 is formed in the distal outersheath tip 3050 to expose the tissue cutting distal end 705 of the blade200. As with various embodiments described above, the window 3056 maydefine at least one cutting edge 3057 that interacts with the rotatingtissue cutting distal end 705 of blade 200 to cut tissue drawn into thewindow 3056. In this embodiment, the outer diameter “OD” of the tissuecutting distal end portion 705 of the blade 200 at the point wherein thedistal end 705 of the blade 200 protrudes distally into the windowopening 3056 is greater than the inner diameter “ID” of the lumen 3054.In some embodiments, for example, the inner lumen diameter “ID” may beapproximately 0.140″ and the blade “OD” may be approximately 0.150″.Such arrangement results in an interference between the tissue cuttingdistal end 705 of the blade 200 and the distal outer sheath tip 3050. Insuch arrangement, the distal portion 711 of the blade 200 essentiallycomprises a cantilevered beam which results in the tissue cutting distalend 705 of the blade 200 being pushed downward (FIG. 97) by the distalouter sheath tip 3050.

In the embodiments depicted in FIGS. 92-97, it may be desirable toprovide an amount of clearance between the distal end 3058 of the distalouter sheath tip 3050 and the curved tip portion 702 of the blade 200.This clearance “C” is illustrated in FIG. 97. Such clearance allowsunimpeded ultrasonic motion of the blade 200. However, it may bedesirable to minimize such clearance “C” to reduce suction loses aroundthe curved tip portion 702 which may hamper the device's ability to cuttissue.

Also, to facilitate the drawing of tissue into the window opening 3056,suction must be applied within the distal outer sheath tip 3050 from asource of suction (not shown) in the various manners described above. Inthis embodiment, for example, a suction path 3080 is provided in thedistal outer sheath tip 3050 as shown in FIGS. 97 and 98. A seal 3090 isjournaled on the distal portion 711 of the blade 200 to establish afluid tight seal at a point wherein the distal portion 711 of the blade200 exits the inner sheath 3070. See FIG. 97. Also in this embodiment,the distal end 3072 of the inner sheath 2070 extends into an opening3055 in the bearing portion 3052 of the distal outer sheath tip 3050 toprovide relative rigid support thereto. As can be seen in FIG. 98, thesuction path 3080 forms a discontinuity in the inner sheath supportsurface 3057 defined by opening 3055. FIG. 99 depicts an alternativedistal outer sheath tip 3050′ wherein the suction path 3080′ does notextend into the opening 3055′ that supports the distal end 3072 of theinner sheath 3070.

Various ultrasonic surgical instruments that employ an outer sheath androtatable cutting member arrangement also face the challenge of outersheath and blade deformation due to heat and high contact forces betweenthose two components. Deformation of the distal tip portion of the outersheath can be reduced by changing the tip material to metal, but thiscan result in the undesirable effect of damaging the blade via galling,which can ultimately result in broken blades and extremely limited bladelife. Such sheath tip blade galling damage can occur due tometal-to-metal contact between the blade and the sheath tip. Thiscondition may be exacerbated when cutting tough tissues such as tendonand the like. As was discussed above, such tough tissues may bias thecutting edges away from each other and force the opposite cutting edgeor face of the blade into contact with the sheath tip, thereby resultingin galling.

Various non-limiting embodiments described herein and their respectiveequivalents may employ a thin friction-reducing material on the innerwall of the tip cavity formed within the distal tip portion of the outersheath or, in alternative embodiments, a low friction or frictionreducing pad may be affixed within the tip cavity to protect the blade.One exemplary embodiment is depicted in FIGS. 100 and 101. As can beseen in those Figures, the outer sheath 900′ that was described abovehas a friction-reducing polymeric coating or pad 3100 therein. Invarious embodiments, the distal tip portion 902′ of the sheath 900′ maybe fabricated from metal such as stainless steel and the frictionreducing material or pad 3100 may be fabricated from, for example,polyimide, carbon-filled polyimide, Teflon®, Teflon-Ceramic, etc. Inthose embodiments in which a pad is employed, the pad may be affixedwithin the tip portion 902′ by, for example, adhesive or a dovetailjoint arrangement. The pad 3100 is preferably configured to match thecorresponding geometry of the blade. For example, as shown in FIG. 101,a blade 3110 that may be substantially similar to blade 200 describedabove, has a distal end portion 3112 that has a central portion 3114that separates two cutting faces 3116, 3118. The cutting faces 3116,3118 have an arcuate shape and have cutting edges 3120 formed on eachedge thereof. In that embodiment, the polymeric pad 3100 also has asimilar arcuately shaped upper surface 3101. The advantage of thisconcept is that it maintains a hard metallic cutting edge (e.g.,stainless steel), which is advantageous for cutting tough tissue. Italso protects the broad cutting faces 3116, 3118 of the blade 200 whenthe pad 3100 is fabricated from softer materials that can otherwisesupport the forces applied to the blade. In addition or in thealternative, the inner wall 903′ of the tip portion 902′ may be coatedwith a friction-reducing coating 3130 of the type described above. Thecoating 3130 may comprise a separate component that is held in place viaadhesive or it may comprise a deposition coating that is directlyadhered to the inner surface 903′ of the tip portion 902′. For example,a Teflon® material may be applied to portions of the inner wall 903′through vapor deposition. The portions of the tip 902′ wherein thecoating is not needed may be masked off using known masking techniquesbefore exposing the tip 902′ to the vapor deposition process.

FIG. 102 depicts a tissue cutting blade end 3112′ that may be coatedwith a relatively hard, low-friction material to increase surfacehardness and reduce friction. In particular, as can be seen in thatFigure, at least portions of the cutting faces 3116′, 3118′ are coatedwith the coating material 3130. In some embodiments, for example, thecoating material may comprise coating materials such as TitaniumNitride, Diamond-Like coating, Chromium Nitride, Graphit iC™, etc. Theblade 3060′ may be employed in connection with an outer sheath tip thatis fabricated from metal (e.g., stainless steel) in order to avoid bladegalling and eventual blade breakage. In alternative embodiments, theentire distal tissue cutting end of the blade may be coated with thecoating material 3130.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the various embodiments described herein will be processedbefore surgery. First, a new or used instrument is obtained and ifnecessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility. Sterilization can also be done by any number of waysknown to those skilled in the art including beta or gamma radiation,ethylene oxide, and/or steam.

In various embodiments, an ultrasonic surgical instrument can besupplied to a surgeon with a waveguide and/or end effector alreadyoperably coupled with a transducer of the surgical instrument. In atleast one such embodiment, the surgeon, or other clinician, can removethe ultrasonic surgical instrument from a sterilized package, plug theultrasonic instrument into a generator, as outlined above, and use theultrasonic instrument during a surgical procedure. Such a system canobviate the need for a surgeon, or other clinician, to assemble awaveguide and/or end effector to the ultrasonic surgical instrument.After the ultrasonic surgical instrument has been used, the surgeon, orother clinician, can place the ultrasonic instrument into a sealablepackage, wherein the package can be transported to a sterilizationfacility. At the sterilization facility, the ultrasonic instrument canbe disinfected, wherein any expended parts can be discarded and replacedwhile any reusable parts can be sterilized and used once again.Thereafter, the ultrasonic instrument can be reassembled, tested, placedinto a sterile package, and/or sterilized after being placed into apackage. Once sterilized, the reprocessed ultrasonic surgical instrumentcan be used once again.

Although various embodiments have been described herein, manymodifications and variations to those embodiments may be implemented.For example, different types of end effectors may be employed. Also,where materials are disclosed for certain components, other materialsmay be used. The foregoing description and following claims are intendedto cover all such modification and variations.

All of the above U.S. patents and U.S. patent applications, andpublished U.S. patent applications referred to in this specification areincorporated herein by reference in their entirety, but only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

1. A method of treating tissue within an aqueous environment comprising:introducing a cutting implement of a surgical instrument into theaqueous environment, the cutting implement having at least one cuttingsurface thereon and at least one ultrasonic portion thereon and beingselectively rotatable within a hollow sheath between cutting positionswherein the at least one cutting surface may be exposed to tissue and anultrasonic position wherein the ultrasonic portion may be exposed to thetissue; rotating the cutting implement within the hollow sheath; cuttingtissue with the at least one cutting surface of the rotating cuttingimplement; positioning the cutting implement in the ultrasonic position;retaining the cutting implement in the ultrasonic position; applyingpressure to tissue with the exposed ultrasonic portion of the cuttingimplement; and applying ultrasonic motion to the cutting implement. 2.The method of claim 1 further comprising: orienting the cuttingimplement within the hollow sheath to an injection position wherein adistal portion of the cutting implement is exposed through the hollowsheath; retaining the cutting implement in the injection position; andinjecting medicament out through the exposed distal portion of thecutting implement.
 3. The method of claim 2 wherein: the surgicalinstrument has a selector switch thereon; said rotating is initiated bymoving the selector switch to a first position; said positioning isinitiated by moving the selector switch to a second position; saidorienting and said retaining the cutting implement in the injectionposition are initiated by moving the selector switch to a thirdposition; and said injecting is initiated by actuating a trigger on thesurgical instrument.
 4. The method of claim 1 further comprising drawingthe tissue into a portion of the hollow sheath during said rotation. 5.The method of claim 4 wherein said drawing comprises applying a suctionbetween the cutting implement and the hollow sheath.
 6. The method ofclaim 4 wherein said drawing comprises applying a suction to a portextending through the cutting implement.
 7. The method of claim 1wherein said rotating is initiated by activating a first switch on thesurgical instrument.
 8. The method of claim 1 wherein said positioningis initiated by activating a second switch on the surgical instrument.9. The method of claim 1 wherein the surgical instrument has a selectorswitch thereon and wherein said rotating is initiated by moving theselector switch to a first position.
 10. The method of claim 9 whereinsaid positioning is initiated by moving the selector switch to a secondposition.
 11. A method of treating tissue within an aqueous environmentcomprising: introducing a cutting implement of a surgical instrumentinto the aqueous environment, the cutting implement having at least onecutting surface thereon and at least one ultrasonic portion thereon andbeing selectively rotatable within a hollow sheath between cuttingpositions wherein the at least one cutting surface may be exposed totissue and an ultrasonic position wherein the ultrasonic portion may beexposed to the tissue; rotatably oscillating the cutting implementwithin the outer hollow sheath; cutting tissue with the at least onecutting surface of the rotatably oscillating cutting implement;positioning the cutting implement in the ultrasonic position; retainingthe cutting implement in the ultrasonic position; applying pressure totissue with the exposed ultrasonic portion of the cutting implement; andapplying ultrasonic motion to the cutting implement.
 12. The method ofclaim 11 further comprising: orienting the cutting implement within thehollow sheath to an injection position wherein a distal portion of thecutting implement is exposed through the hollow sheath; retaining thecutting implement in the injection position; and injecting medicamentout through the exposed distal portion of the cutting implement.
 13. Themethod of claim 11 further comprising drawing the tissue into a portionof the hollow sheath during said rotatably oscillating.
 14. The methodof claim 13 wherein said drawing comprises applying a suction betweenthe cutting implement and the hollow sheath.
 15. The method of claim 13wherein said drawing comprises applying a suction to a port extendingthrough the cutting implement.
 16. The method of claim 11 wherein saidrotatably oscillating is initiated by activating a first switch on thesurgical instrument.
 17. The method of claim 11 wherein said positioningis initiated by activating a second switch on the surgical instrument.18. The method of claim 11 wherein the surgical instrument has aselector switch thereon and wherein said rotatably oscillating isinitiated by moving the selector switch to a first position.
 19. Themethod of claim 18 wherein said positioning is initiated by moving theselector switch to a second position.